Clinical trial NCT03208985
Conditions: Emergency Contraception
Keywords: Emergency contraception
Sponsor: HRA Pharma
Start date: 2017-05-23; Completion date: 2018-06-14
Enrollment: 1270 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.

Detailed description:
All potential subject coming to a site looking to purchase EC will be offered to participate in the study. Subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. Subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information.

Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.

Arms: arm 1: One tablet of 30 mg of ulipristal acetate for emergency contraception
Interventions: intervention 1: Use Phase (Ulipristal Acetate, 30 mg)
Intervention descriptions: intervention 1: All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate.

Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet).

Protocol documents:
Prot_000.pdf: 
 
HRA Pharma 
 
 
ELLA® ACTUAL USE TRIAL PROTOCOL 
 
 
Title: 
A Multi-Center, Open-Label Trial Investigating 
Behavior Related to ella® Use in a Simulated OTC 
Environment (LIBRella) 
Compound: 
ulipristal acetate 30 mg 
Phase: 
Phase IV 
Protocol Number: 
151032-001 
Protocol Version / Date: 
Final v3.1 / 5 May 2017 
Sponsor’s Name and 
Address:  
Laboratoire HRA Pharma 
15 rue Beranger 
75003 PARIS  
France 
 
Pharmacovigilance Contact 
Information 
HRA Pharma Pharmacovigilance  
15 rue Béranger 75003 PARIS,  
fax: + 33 1.42.77.03.52  
e-mail : pharmacovigilance@hra-pharma.com 
 
24-Hour Adverse Event 
Reporting Number 
1-800-530-3680 
 
 
The information contained in this document is proprietary and confidential and is intended for the 
exclusive use of the designated addressee. Any disclosure, reproduction, distribution, or other 
dissemination of this information outside of HRA Pharma or its Affiliates, Licensees, or their 
Regulatory Agencies is strictly prohibited. If you have received this document in error, please 
contact HRA Pharma. 


Sarah Farnsworth
Digitally signed by Sarah Farnsworth 
DN: cn=Sarah Farnsworth, o=PEGUS Research, Inc., ou=VP, 
Scientific Affairs, email=FarnsworthS@pegus.com, c=US 
Reason: I am approving this document 
Date: 2017.05.16 08:54:37 -06'00'
Russell D. Bradford
Digitally signed by Russell D. Bradford 
DN: cn=Russell D. Bradford, o=PEGUS Research, 
Inc., ou, email=bradfordr@pegus.com, c=US 
Date: 2017.05.16 08:55:34 -06'00'


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Document History 
 
Document 
Version / Date 
Summary of Changes 
Final protocol 
Final v1.0_22Dec2016 
n/a 
Amended protocol 
Final v1.1_26Jan2017 
In response to IRB review: 
Schedule of Activities updated to 
include specification on timing and 
method of subject study drug 
payment reimbursement. 
Section 3.3.1 Inclusion Criteria 
was updated to add “Seeking the 
use of emergency contraception”. 
Section 5.2.2 and Section 12.3 
clarification added that assent of 
adolescent subjects will be 
gathered where state or local laws 
do not allow for waiver of parental 
consent. 
Section 5.5 Flow chart of activities 
revised to include explicit consent 
to gather sensitive data. 
Section 12.3 Subject Information 
and Consent updated to specify 
retention of anonymous study data 
from screen fail, disqualified to 
participate and non-consented 
subjects. 
Sections 12.2 and 12.3 removed 
references to waiver of parental 
consent.  Removed reference to 
birth date as an example of PII 
collected and clarified that PII 
collected will be for compensation 
and follow-up purposed only. 
Sponsor decision throughout, 
revised number of health clinics 
from approximately 20 to 
approximately 25 thereby 
increasing total investigative sites 
to approximately 35. 


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Amended Protocol 
Final v2.0_06Mar2017 
The following changes were made 
in response to feedback received 
from FDA in a teleconference on 
24Feb2017:  
Added breastfeeding as an 
exclusion criterion to participate in 
Use Phase 
Added premenarchal status as an 
exclusion criterion to participate in 
Use Phase 
Urine-based pregnancy testing at 
enrollment was added as a study 
procedure to confirm pregnancy 
status prior to allowing subjects to 
purchase (as pregnancy is an 
exclusion criterion to participate in 
Use Phase).  
Section 5.5 Flow chart of activities 
revised to include new exclusion 
from Use Phase following positive 
pregnancy test at enrollment. 
Amended Protocol 
Final v3.0_27Apr2017 
The following changes were made 
in response to written comments 
received from FDA on 03-Apr-
2017, reference ID 4078573: 
Secondary Endpoint D reworded to 
reflect that breastfeeding was 
added as an exclusion criterion to 
the Use Phase in v2.0. 
Added Secondary Endpoint I 
Section 2.3: Additional relevant 
DFL messages added for 
Secondary Endpoint D. Secondary 
Endpoint I and rationale added 
Section 3.1 Added clarifying text 
that study staff will not answer 
subject questions about the IP, but 
will redirect them to the labeling.  
Section 3.3: Sample size 
increased to 175 for adolescents, 
with approximately 50 under the 


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age of 15 and 125 ages 15-17. 
Supplemental rationale for active 
recruitment of adolescents was 
added.  
Section 4.3.2: Rationale for 
maximum purchase of 9 packages 
of IP added.  
Section 5.5 Flow chart of activities 
revised to reflect revised approach 
to adolescent recruitment 
Section 6.3: Rationale for not 
imposing a low literacy quota in the 
study was added. 
Section 8.4.2: Complete definitions 
of Correct, Acceptable, and 
Incorrect Selectors added 
Section 8.4.3: Process for 
physician mitigation added.  
Section 9.3: Added a secondary 
analysis by subject rather than 
dosing instance for relevant 
endpoints. 
Section 9.3.3.1: Clarified analysis 
for Secondary Endpoint D 
Section 9.3.3.3: Clarified that other 
proportions will be presented with 
self-selection endpoints, such as 
[(cell A + cell D) / (cell A + cell B + 
cell C + cell D)] and [cell D/ (cell B 
+ cell D)]. 
Amended Protocol 
Final v3.0_27Apr2017 
In response to IRB review: 
References to adolescent 
recruitment changed from “targets” 
to “goals,” in the setting of capping 
enrollment for adults (to allow 
room for an adolescent subgroups 
of FDA-requested size). 
 
 


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Protocol Summary 
 
Study Title A Multi-Center, Open-Label Trial Investigating Behavior Related 
to ella® Use in a Simulated OTC Environment (LIBRella) 
Phase Phase IV 
Background and 
Rationale 
ella® (ulipristal acetate) is proposed for a prescription to over-the-
counter (Rx-to-OTC) switch. This actual use trial (AUT) will be 
conducted to demonstrate appropriate consumer behavior when 
using the product in the absence of a physician or other learned 
intermediary. This study will be conducted to obtain 
measurements of consumer behaviors related to the actual use of 
the product, in particular the compliance with key communication 
messages presented in the Drug Facts Label (DFL). 
Objective and 
Endpoints 
The objective of this study is to evaluate the adequacy of the 
proposed OTC labeling to guide appropriate consumer behavior 
by measuring pre-specified endpoints. The determination of the 
following primary endpoints and other measures is based on the 
potential clinical consequences of a consumer failing to heed 
each key label instruction and the concerns the United States 
Food and Drug Administration (US FDA) has raised with regard to 
the potential for misuse of the product in an OTC setting. 
Endpoints are designated either as Actual Use endpoints or Self-
Selection endpoints. 
Primary Endpoints 
A. Actual Use:  Proportion of dosing instances among user 
population taken within 120 hours (5 days) of most recent 
episode of unprotected sex. 
B. Actual Use:  Proportion of dosing instances among user 
population in which no more than one tablet was taken. 
C. Self-Selection:  Proportion of female selectors who are not 
pregnant at the time of selection decision. 
Secondary Endpoints 
D. Self-Selection:  Proportion of female selectors who are not 
breastfeeding at the time of selection decision. 
E. Self-Selection:  Proportion of self-selection population who 
make a correct selection decision. 
F. Actual Use:  Proportion of dosing instances among user 
population in which hormonal birth control (HBC) is not 
taken for 5 days after taking ella®. 
G. Actual Use:  Proportion of dosing instances among user 
population associated with use of hormonal contraceptives 
in the same cycle after taking ella® in which subject 
reports using a condom (or other barrier method) every 
time they have sex until their next menstrual period. 
H. Actual Use:  Proportion of user population who do not use 


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the study product more than once in the same menstrual 
cycle. 
I. Self-Selection/Actual Use:  Proportion of self-selection 
population taking one of the “ask a doctor or pharmacist 
before use” products who do not select, who select but do 
not use or who report contacting a healthcare provider or 
pharmacist.  
Other Measures 
J. Actual Use:  Proportion of user population who used a 
HBC method sometime during the previous two months. 
K. Actual Use:  Proportion of user population who use any 
EC on more than one occasion within the study period. 
L. Actual Use:  Proportion of user population who report 
becoming pregnant within the study period. 
Study Design  This is an observational open-label, multicenter, 6-week study 
designed to mimic an OTC-like environment in which subjects will 
use ella® after making a self-selection and purchase decision 
about the product based only on their reading of the DFL and 
other information on the package. The study will increase 
understanding regarding how subjects will use the medication in 
an OTC-like environment. 
Number of 
Subjects 
A total of approximately 950 subjects will be allowed to purchase 
the study medication. Assuming that about 80% of those who 
purchase will both use the study medication and participate in at 
least one follow up telephone call, that will yield an actual use 
population among which to evaluate the primary endpoints of 760 
subjects. In order to allow for a subgroup of adolescent users, 
adult purchasers will be constrained to no more than 775, 
allowing for an adolescent subgroup of approximately 175 (or 
more, should a higher proportion naturally occur). Among 
adolescents, enrollment will be further broken down to include 
approximately 50 purchasers under the age of 15 and 
approximately 125 purchasers ages 15-17. 
Methods The nature of the indication (emergency contraception, EC) 
makes recruitment for the trial challenging. By definition a woman 
does not know in advance that she will need EC, and when she 
does need it (i.e., after she has had unprotected sex), she needs 
to take it very quickly. Therefore, a typical passive advertising 
campaign aimed at consumers interested in the indication (the 
approach typically used in AUTs) is unlikely to be effective in this 
study.  
Subjects will be recruited at the point of OTC-like sale in women’s 
health clinics and in retail pharmacy study sites. Sites will be 
chosen which currently sell EC in an OTC or OTC-like setting and 
which have enough EC sales to meet recruitment goals. 
Approximately 35 sites will be used, composed of approximately 


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25 women’s health clinics and 10 retail pharmacy research sites. 
In order to be as representative as possible of the OTC EC-
seeking population, when potential subjects come to a site 
looking to purchase EC, they will be offered the opportunity to 
participate in the study. Potential subjects will be directed to study 
staff for a face-to-face interview and screened for initial study 
inclusion criteria. 
Subjects who meet the initial screening inclusion criteria for the 
study will be given an (empty) ella® package and will be allowed 
as much time as they need to review the information on the 
outside of the entire package. Subjects will be asked to make a 
selection decision regarding whether the product is appropriate 
for them to use or not.  Reasons for selection and deselection will 
be recorded.  Those that select the product will then be told the 
cost of the investigational product and will be asked if they would 
like to purchase it for their own use. Reasons for any non-
purchase and purchase decisions will be recorded.  
Following the purchase decision, subjects will provide 
demographic information and limited medical history. The Rapid 
Estimate of Adult Literacy in Medicine (REALM)1 or Rapid 
Estimate of Adolescent Literacy in Medicine (REALM-Teen)2 will 
then be administered. Subjects will be asked to sign the informed 
consent and then provide information about current medication 
use. Subjects who sign consent will provide a urine sample for 
pregnancy testing.  Subjects with a positive pregnancy test result 
will be informed that the test was positive, will be asked the 
selection and purchase question again to better assess their self-
selection decision, and then excluded from further study 
participation. Qualified subjects will be allowed to purchase the 
study product and told they may return to the site at any time to 
resupply. Subjects will not be allowed to purchase more than 3 
one-dose packages at a time or more than 9 one-dose packages 
during the study period (although this will not be communicated to 
the subjects unless they attempt to purchase more than that). 
While any request for more will be denied, the request will be 
recorded. 
Subsequent contact will be by up to two telephone interviews 
conducted by trained nurses (interviewers) at a central research 
site. Subjects will be contacted by phone at Week-2 (Day 14 with 
an allowable window of ±3 days) and at Week-6 (Day 42±4 days) 
to gather information on if, how and when the subject took the 
product, any adverse events (AEs), concomitant medications, and 
other actions the subject may have taken related to the use of the 
product. Results of the End-of-Study pregnancy test will be 
reported by subjects and recorded. 
Once all steps of the final telephone interview are completed, the 
subject will be instructed to return leftover study medication, if 
any, and empty packaging to PEGUS and will exit the study. 


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Statistical 
Analysis 
A summary of the disposition of subjects (including responders, 
self-selection population, purchasers and users) and reasons 
for exclusion from these populations will be provided. 
Demographic characteristics, medical history and other 
background information will be summarized for the responder, 
self-selection, purchaser, and user populations. 
Frequencies and percentages will be presented for categorical 
data, mean, standard deviation (SD); median, and range will be 
presented for numerical data. 
Frequencies, percentages and 2-sided 95% confidence 
intervals (CIs) will be calculated for the primary and secondary 
endpoints using the exact method. For the primary endpoints, it 
will be concluded that the established target threshold is 
reached if the lower limit of the CI of the point estimate is equal 
to or exceeds the value of the pre-determined threshold.  
Endpoints and demographics will be presented for subgroups of 
interest, with subjects dichotomized on the corresponding 
variables, which include (but are not necessarily limited to) 
literacy, gender, age (adolescent vs. adult women), and history of 
hormonal birth control use. 
Several of the endpoints are based on dosing instance, rather 
than by subject, as subjects have the potential to take more than 
one dose over the course of the study.  Correctness of selection 
or behavior can only be evaluated at the time of use, rather than 
at the time of purchase.  However, for each of those endpoints, a 
secondary analysis by subject will also be presented. 
A more detailed description of planned data analysis procedures 
will be found in the Statistical Analysis Plan (SAP) which will be 
approved and signed before the database is locked. 
Study Duration The duration of this study is expected to be around 6 months 
(from first subject enrolled in the study until last subject last visit), 
with subject recruitment proposed to start mid-Q2 2017 and end 
in Q4 2017. The actual overall study duration or subject 
recruitment period may vary. 
CRO PEGUS Research, Inc. 
331 South Rio Grande, Suite 100 
Salt Lake City, UT  84101 
Date 27 April 2017 
 


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Schedule of Activities 
 
The schedule of activities table provides an overview of the protocol visits and procedures. Refer to the STUDY PROCEDURES and  
ASSESSMENTS sections of the protocol for detailed information on each procedure and assessment required for compliance with 
the protocol. The investigator may schedule visits (unplanned visits) in addition to those listed on the schedule of activities, in order to 
conduct evaluations or assessments required to protect the well-being of the subject. 
Visit Procedure 
Intercept 
Recruitment  
Enrollment Visit / 
First Purchasea 
 
Week 2 
Week 6 
End of Study 
/ Early 
Terminatione 
  
 
Day 1 
14±3 Days 
42±4 Days 
 
Invitation to participate  
X 
 
 
 
 
Review screening / study inclusion criteria 
 
X 
 
 
 
Subject reviews outer packaging and makes 
selection and purchase decision 
 
X 
 
 
 
Collect demographics and relevant medical 
history 
 
X 
 
 
 
Administer REALM or REALM-Teen testc 
 
X 
 
 
 
Study exclusion/inclusion criteria assessed 
for eligibility to continue 
 
X 
 
 
 
Subject signs informed consent  
 
X 
 
 
 
Urine pregnancy test performedh 
 
X 
 
 
 
Collect current/regular relevant medications 
and associated conditionsb 
 
X 
 
 
 
Purchase transaction conductedd 
 
X 
 
 
 
Telephone interviews  
 
 
X 
X 
X 
End-of-study telephone interview 
 
 
 
 
X 
Record End-of-study pregnancy test resultsf 
 
 
 
 
X 
Concomitant medications 
 
X 
→ 
→ 
X 
Adverse Events 
 
X 
→ 
→ 
X 
Reimbursement for cost of study medication 
(After all subjects complete the study) g 
 
 
 
 
X 
Abbreviations: → = ongoing/continuous event; REALM = Rapid Estimate of Adult Literacy in Medicine; REALM-Teen = Rapid Estimate of 
Adolescent Literacy in Medicine 


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a. 
Day relative to first purchase of study medication (Day 1). 
b. 
Subjects will be asked to provide a list of any conditions they have and any medications they are taking. Females only. 
c. 
REALM or REALM-Teen will be conducted for all subjects who participate in the enrollment interview regardless of self-selection/purchase 
decision. 
d. 
Subjects will be allowed to purchase any amount of study medication up to 3 packages at the baseline visit, or return to the site at any time 
during their use phase and purchase the maximum amount (up to 9 packages) allowed during subsequent treatment weeks (6 weeks). 
e. 
Early termination interview will be conducted during the study if the subject is discontinued or withdraws consent prior to Week 6. 
f. 
Subjects are provided with a urine pregnancy test at enrollment and asked to keep it until directed to use it at the end of study. 
g. 
After study closeout, subjects are reimbursed the purchase price paid for any study drug.The subjects are not notified of this when enrolling in 
the study in order to maintain an OTC-like environment for selection/purchase of the study drug. Subjects will be notified of and provided with 
the reimbursement via mail following study closeout. 
h. 
Subjects with a positive pregnancy test will be asked to make a selection decision again to better assess self-selection and then will be 
excluded from the use phase. 
 
 


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Glossary and Abbreviations 
 
AE 
Adverse Event 
AUT 
Actual Use Trial 
CI 
Confidence Interval 
CIL 
Consumer Information Leaflet 
CRF 
Case Report Form 
CRO  
Contract Research Organization  
DCI 
Data Collection Instrument 
DFL 
Drug Facts Label 
DMP 
Data Management Plan 
EC 
Emergency Contraceptive 
EDC 
Electronic Data Capture 
EDP 
Exposure During Pregnancy 
EOS 
End-of-Study 
FDA 
Food and Drug Administration 
GCP  
Good Clinical Practice  
HBC 
Hormonal Birth Control 
HIV 
Human Immunodeficiency Virus 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IP 
Investigational Product 
IRB 
Institutional Review Board 
LCS 
Label Comprehension Study 
MedDRA 
Medical Dictionary for Regulatory Activities 
OTC 
Over-the-Counter 
PBOS 
Plan B One Step 
PHI 
Personal Health Information 
PII 
Personal Identifiable Information 
POP 
Progestin-Only Pill 
PT 
Preferred Term 
PV 
Pharmacovigilance 
REALM 
Rapid Estimate of Adult Literacy in Medicine 
REALM-Teen 
Rapid Estimate of Adolescent Literacy in Medicine 
Rx 
Prescription 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SOC 
System Organ Class 


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SOP 
Standard Operating Procedure 
SSS 
Self-Selection Study 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
UPA 
Ulipristal Acetate 
US 
United States 
USPS 
United States Postal Service 
 
 
 


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Table of Contents 
1 
INTRODUCTION ................................................................................................... 18 
1.1 
Indication ..................................................................................................... 18 
1.2 
Background and Rationale ........................................................................... 18 
2 
STUDY OBJECTIVE AND ENDPOINTS ................................................................ 18 
2.1 
Objective ...................................................................................................... 18 
2.2 
Endpoints ..................................................................................................... 18 
 
Primary Endpoints ............................................................................ 18 
 
Secondary Endpoints ....................................................................... 18 
 
Other Measures ................................................................................ 19 
2.3 
Rationale for Designation of Study Endpoints .............................................. 19 
3 
STUDY DESIGN .................................................................................................... 24 
3.1 
Naturalistic Design ....................................................................................... 24 
3.2 
Study Sites................................................................................................... 25 
 
Site Training and Procedural Integrity ............................................... 25 
3.3 
Subject Selection ......................................................................................... 25 
 
Inclusion Criteria: Self-Selection Phase ............................................ 26 
 
Exclusion Criteria: Use Phase .......................................................... 27 
 
Recruitment Methods ....................................................................... 27 
3.4 
Randomization ............................................................................................. 28 
3.5 
Data Collection ............................................................................................ 28 
3.6 
Test Materials .............................................................................................. 29 
3.7 
Study Administrative Structure ..................................................................... 29 
4 
STUDY TREATMENTS .......................................................................................... 29 
4.1 
Allocation to Treatment ................................................................................ 29 
4.2 
Breaking the Blind ........................................................................................ 29 
4.3 
Drug Supplies .............................................................................................. 29 
 
Formulation and Packaging .............................................................. 29 
 
Preparation and Dispensing ............................................................. 30 
 
Drug Storage and Accountability ...................................................... 30 
4.4 
Drug Administration ..................................................................................... 31 
 
Compliance ...................................................................................... 31 
4.5 
Concomitant Medication(s) .......................................................................... 31 
4.6 
Rescue/Escape/Salvage Therapy ................................................................ 31 
4.7 
Batch Recall ................................................................................................. 31 
5 
STUDY PROCEDURES ......................................................................................... 31 
5.1 
Pre-Interview Activities ................................................................................. 31 
5.2 
Study Period ................................................................................................ 32 


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Enrollment Visit, Self-Selection/Purchase Decision .......................... 32 
 
After Purchase Decision and Before Use Phase ............................... 32 
5.3 
Use Phase ................................................................................................... 33 
 
Unscheduled Study Site Visits .......................................................... 33 
 
Telephone Interviews ....................................................................... 33 
5.4 
Subject Withdrawal (Early Termination) ....................................................... 34 
5.5 
Study Flow ................................................................................................... 36 
6 
ASSESSMENTS .................................................................................................... 37 
6.1 
Screening Assessment ................................................................................ 37 
6.2 
Enrollment Interview .................................................................................... 37 
6.3 
Reading Level Assessment .......................................................................... 37 
6.4 
Interim Follow-Up Telephone Interviews ...................................................... 38 
6.5 
End-of-Study/Early Termination Telephone Interview .................................. 39 
6.6 
Pregnancy Testing ....................................................................................... 39 
7 
ADVERSE EVENT REPORTING ........................................................................... 40 
7.1 
Adverse Events ............................................................................................ 40 
7.2 
Reporting Period .......................................................................................... 40 
7.3 
Definition of an Adverse Event ..................................................................... 40 
7.4 
Abnormal Test Findings ............................................................................... 41 
7.5 
Serious Adverse Events ............................................................................... 41 
 
Protocol-Specified Serious Adverse Events ...................................... 42 
7.6 
Hospitalization ............................................................................................. 42 
7.7 
Severity Assessment ................................................................................... 43 
7.8 
Causality Assessment .................................................................................. 43 
7.9 
Exposure During Pregnancy ........................................................................ 44 
7.10 Withdrawal Due to Adverse Events .............................................................. 45 
7.11 Eliciting Adverse Event Information .............................................................. 45 
7.12 Reporting Requirements .............................................................................. 45 
 Serious Adverse Event Reporting Requirements .............................. 45 
 Non-Serious Adverse Event Reporting Requirements ...................... 46 
 Sponsor Reporting Requirements to Regulatory Authorities ............. 46 
8 
DATA MANAGEMENT ........................................................................................... 46 
8.1 
EDC System ................................................................................................ 46 
8.2 
Data Management Plan ............................................................................... 46 
8.3 
Conceptual Approach to Self-Selection ........................................................ 46 
8.4 
Classification Activities ................................................................................. 47 
 
Selection Decision ............................................................................ 47 
 
Appropriate to Use ........................................................................... 48 


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Physician Mitigation .......................................................................... 49 
 
Coding of Open-ended Responses ................................................... 50 
9 
DATA ANALYSIS/STATISTICAL METHODS ......................................................... 50 
9.1 
Sample Size Determination .......................................................................... 50 
9.2 
Analysis Populations .................................................................................... 51 
9.3 
Endpoint Analysis ........................................................................................ 52 
 
Primary Endpoint Analysis ................................................................ 52 
 
Target Thresholds ............................................................................ 53 
 
Secondary Endpoint Analysis ........................................................... 54 
 
Other Measures Analysis ................................................................. 57 
9.4 
Safety Analysis ............................................................................................ 58 
9.5 
Interim Analysis ........................................................................................... 58 
9.6 
Missing Data ................................................................................................ 58 
9.7 
Open-ended Data ........................................................................................ 58 
10 DATA HANDLING AND RECORD KEEPING ......................................................... 58 
10.1 Data Collection Instruments / Electronic Data Record .................................. 58 
10.2 Study Documentation ................................................................................... 59 
10.3 Confidentiality of Study Documents and Electronic Records ........................ 59 
11 QUALITY CONTROL AND QUALITY ASSURANCE .............................................. 59 
12 ETHICS .................................................................................................................. 60 
12.1 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ........ 60 
12.2 Ethical Conduct of the Study ........................................................................ 60 
12.3 Subject Information and Consent ................................................................. 61 
12.4 Liability and Insurance ................................................................................. 62 
12.5 Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
 
62 
12.6 Mandatory Reporting ................................................................................... 62 
13 SPONSOR DISCONTINUATION CRITERIA .......................................................... 63 
14 PUBLICATION OF STUDY RESULTS ................................................................... 63 
14.1 Communication of Results by the Sponsor................................................... 63 
15 EMERGENCY CONTACTS ................................................................................... 63 
16 STUDY DURATION AND DATES .......................................................................... 63 
17 REFERENCES ...................................................................................................... 64 
18 APPENDICES ........................................................................................................ 65 
18.1 Mock Package and Drug Facts Label ........................................................... 65 
18.2 Consumer Information Leaflet ...................................................................... 66 


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List of In-Text Tables and Figures 
 
Figure 1  Study Procedures Flowchart .......................................................................... 36 
 
Table 1  Endpoint Rationale for Primary and Secondary Endpoints ............................... 19 
Table 2 REALM Test Grade-Equivalent Reading Levels ............................................... 38 
Table 3 REALM-Teen Test Grade-Equivalent Reading Levels ...................................... 38 
Table 4 Self-Selection Decision Outcomes .................................................................... 47 
Table 5  Two-sided 95% CIs for Various Sample Sizes Around 85% Point Estimate ..... 51 


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1 
INTRODUCTION 
ella® (ulipristal acetate) is proposed for a prescription to over-the-counter (Rx-to-OTC) 
switch. This study is designed to assess whether consumers will use the product in a 
manner consistent with the labeling. A Drug Facts Label (DFL) for the nonprescription 
version of ella® has been drafted and evaluated in a pivotal label comprehension study 
(LCS). This protocol describes the next stage of the development program, a pivotal self-
selection (SS) and actual use trial (AUT), which will provide measures of how and when 
consumers select to use and use the product in an OTC-like setting. 
1.1 
Indication 
The proposed labeled “Purpose” for nonprescription ulipristal acetate 30 mg is 
“Emergency contraceptive.” The proposed labeled “Use” for nonprescription ulipristal 
acetate 30 mg is “for women to reduce chance of pregnancy after unprotected sex (if a 
contraceptive failed or if you did not use birth control).” 
1.2 
Background and Rationale 
This AUT is designed to demonstrate that consumers will select and use ella® in a 
manner consistent with the labeling.  
2 
STUDY OBJECTIVE AND ENDPOINTS 
2.1 
Objective 
The objective of this study is to evaluate the behavior of subjects in an OTC-like setting 
when selecting and using ella®. 
2.2 
Endpoints 
The determination of primary and secondary endpoints has been made based on the 
potential clinical consequences of a consumer failing to heed each key label instruction 
and the expressed concerns of the United States Food and Drug Administration (US 
FDA) about the potential for misuse of the product in an OTC setting. The rationale 
behind selection and prioritization of endpoints is summarized below in Section 2.3. The 
appropriateness of behaviors will be assessed by measuring the endpoints as per the 
endpoint analysis listed in Section 9.3. 
 
 Primary Endpoints 
A. Actual Use:  Proportion of dosing instances among user population taken within 
120 hours (5 days) of most recent episode of unprotected sex. 
B. Actual Use:  Proportion of dosing instances among user population in which no 
more than one tablet was taken. 
C. Self-Selection:  Proportion of female selectors who are not pregnant at the time 
of selection decision. 
 Secondary Endpoints 
D. Self-Selection:  Proportion of female selectors who are not breastfeeding at the 
time of selection decision 


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E. Self-Selection:  Proportion of self-selection population who make a correct 
selection decision. 
F. Actual Use:  Proportion of dosing instances among user population in which 
hormonal birth control (HBC) is not taken for 5 days after taking ella®. 
G. Actual Use:  Proportion of dosing instances among user population associated 
with use of hormonal contraceptives in the same cycle after taking ella® in which 
subject reports using a condom (or other barrier method) every time they have 
sex until their next menstrual period. 
H. Actual Use:  Proportion of user population who do not use the study product 
more than once in the same menstrual cycle. 
I. 
Self-Selection/Actual Use:  Proportion of self-selection population taking one of 
the “ask a doctor or pharmacist before use” products who do not select, who 
select but do not use or who report contacting a healthcare provider or 
pharmacist  
 
 Other Measures 
J. Actual Use:  Proportion of user population who used a HBC method sometime 
during the past two months. 
K. Actual Use:  Proportion of user population who used any emergency 
contraceptive (EC) on more than one occasion within the study period. 
L. Actual Use:  Proportion of user population who report becoming pregnant within 
the study period. 
2.3 
Rationale for Designation of Study Endpoints 
The determination of endpoints and designation as primary or secondary endpoints has 
been made based on the potential clinical consequences of a consumer failing to heed 
each key label instruction and FDA’s concerns regarding potential product misuse. Each 
endpoint is listed in Table 1 below, with the DFL messages relevant to the endpoint, 
followed by the rationale underlying the classification as a primary or secondary 
endpoint. Note that the “Other Measures” listed above in Section 2.2.3 are not 
endpoints. Rather, they are descriptive only, and will be used to help characterize the 
study population in the analysis. 
Table 1  Endpoint Rationale for Primary and Secondary Endpoints 
Endpoints 
Relevant DFL Message(s) 
 
 
Primary 
 
A 
Actual Use:  Proportion of dosing 
instances among user population taken 
within 120 hours (5 days) of most recent 
episode of unprotected sex.  
Directions: Take one tablet as soon as 
possible and no later than 120 hours (5 
days) after unprotected sex. 
 
 
 
 
Rationale:  The Sponsor proposes to test this message as a primary endpoint 
because it communicates directions for effective use of ella®, and the limited time-
window for its effective use. Use of ella® after 5 days diminishes the product’s 
efficacy, although it is not expected to introduce any drug-related risks. This 


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endpoint will allow confirmation that consumers do not take ella® later after 
unprotected intercourse than recommended in the product label. 
 
 
 
B 
Actual Use:  Proportion of dosing 
instances among user population in 
which no more than one tablet was 
taken. 
Directions: Do not take more than one 
tablet. 
 
 
 
 
Rationale:  The Sponsor proposes to test this message as a primary endpoint in 
the context of FDA’s recommendation to demonstrate in an AUT whether 
consumers misuse ella® with intake of more than the recommended dose.  This is 
proposed as a primary endpoint despite the fact that, while taking one tablet is 
essential to effectiveness of the product, dose-finding studies using up to 200 mg 
of ulipristal acetate (UPA) (more than 6 times the intended 30 mg dose) 
demonstrated no safety concerns (HRA2914-503), suggesting it is likely that 
taking more than the recommended dose is likely to impose little or no additional 
risk in women. 
 
 
 
C Self-Selection:  Proportion of female 
selectors who are not pregnant at the 
time of selection decision.  
Warnings: Do not use if you are already 
pregnant (because it will not work) 
 
 
 
 
Rationale:  The Sponsor proposes to test this message as a primary endpoint as it 
would allow the study to confirm that consumers do not select or take ella® if they 
are already pregnant, although the available safety data are reassuring for 
pregnant women exposed to ella®. 
 
 
 
 
 
 
Secondary 
 
D Self-Selection:  Proportion of female 
selectors who are not breastfeeding at 
the time of selection decision. 
Warnings: Do not use if you are 
breastfeeding 
 
 
 
 
Rationale:  While it has been shown that UPA and its metabolite are both excreted 
in breastmilk over the first 120 hours after administration, UPA is unlikely to have 
any detrimental effects on the newborn infant if ingested in breast milk, given the 
mechanism of action of UPA and the fact that there is no role for progesterone in 
the newborn infant. To date, no safety signal has been identified in newborns 
breastfed by women who have taken UPA 30mg.  
 
Because breastfeeding is not a contraindication for use of ella® in the prescription 
setting (though it is not recommended because of a lack of clinical data), this has 
been designated as a secondary endpoint in this AUT. 
 
 
 
E 
Self-Selection:  Proportion of self-
selection population who make a correct 
• 
Do not use if you are already 
pregnant 


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selection decision. 
• 
Do not use for regular birth control 
• 
Do not use more than once in the 
same menstrual cycle 
• 
Do not use if you are breastfeeding 
• 
Use: for women to reduce chance 
of pregnancy after unprotected sex  
• 
Allergy alert: Do not use if you have 
ever had an allergic reaction to any 
of the ingredients 
 
 
 
 
Rationale: The main goal of the AUT is to assess actual use of ella®. Given that 
potential clinical consequence of incorrect selection is unlikely to be serious, the 
Sponsor proposes to test correct self-selection of potential consumers as a 
secondary endpoint. 
 
 
 
F 
Actual Use:  Proportion of dosing 
instances among user population in 
which HBC is not taken for 5 days after 
taking ella®. 
Directions: After taking this product; 
users of birth control pills, patch or 
vaginal ring after use of this product: 
Do not use birth control pills, patch or 
vaginal ring for 5 days after taking this 
product. If you do, it may block the 
ability of both this product and your 
birth control to work. 
 
 
 
 
Rationale: The concern about starting HBC within 5 days after taking ella® relates 
to a theoretical decrease in the efficacy of ella® resulting from an interaction 
between ella® and progestins in HBC products. In reality it is uncertain to what 
extent the efficacy of ella® is affected or, indeed whether it is affected at all.  
The recommendation to delay starting HBC after taking ella® stems from a single 
study by Brache et al published in 20153. The study was designed to explore a 
possible interaction between ella® and HBC, when HBC was started immediately 
after taking ella®. It was a small study of just 49 women who were not using HBC 
prior to using ella®, and who took ella® when an ovarian follicle had reached at 
least 14 mm in diameter and so were soon to ovulate; that is, at the point in the 
menstrual cycle when ovulation was already most likely to occur. The following 
day, half of the women started an HBC (a progestin-only pill, POP) while the 
others started a placebo. The key finding was that 44% of women who started 
HBC ovulated within 5 days of taking ella® while only 10% of women in the 
placebo group ovulated in that time frame. Notably, over 50% of women who 
started HBC after ella® did not ovulate and so were not at risk of pregnancy. 
Nevertheless, the theoretical concern was that starting HBC immediately after 
ella® use might reduce the efficacy of ella®. 
This was a small pharmacodynamic study of just 49 women, and the 
recommendation to delay the start or restart of HBC is based on observing just 11 
women ovulating. Most importantly, the study was not designed with pregnancy as 


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an endpoint. Nevertheless, the Sponsor took a conservative and cautious position 
in changing the prescription ella® label to reflect this theoretical concern, hence 
the advice to wait 5 days before starting or restarting HBC. However, because of 
all the limitations of the Brache study, the medical community cannot agree 
whether or not this recommendation is important. In Europe, this instruction has 
not been added to the ella® label and the failure rate of ella® remains low. 
The situation pertaining to use of ella® followed by HBC under OTC conditions is 
different. In the Brache study, the women had not taken HBC prior to using ella® 
and they took ella® in the presence of a large pre-ovulatory follicle, i.e., on the 
verge of ovulating. In the OTC situation, the recommendation to delay starting 
HBC applies only to women who have already been taking HBC prior to using 
ella® (since to acquire a new supply of HBC will require a prescription). Thus these 
ella® users are likely to be women who are seeking EC because they have missed 
pills. Unlike the women in the Brache study, these women are at very low risk of 
pregnancy. HBC use suppresses ovarian activity and it takes time for the ovary to 
recover when the pill is stopped. In a Cochrane review of the effect of missed pills 
on fertility, Zapata et al4 reviewed a number of pharmacodynamic studies in which 
pills were deliberately missed. They concluded that even after missing up to 14 
days of HBC (pills) ovulation is uncommon. In 207 women who missed pills for 
between 8 and 11 days, there were no ovulations and in women who did ovulate 
(usually following missed pills for longer intervals) the cycle was not normal, 
follicles were small, progesterone levels were low and cervical mucus hostile.  
So, in conclusion, if a woman buys ella® over the counter and has a supply of 
HBC, which she wants to restart after ella® use, should she fail to follow the 
instructions to delay restarting HBC, she is highly unlikely to get pregnant. 
Accordingly, the Sponsor proposes that the percentage of women who delay 
re/start of the HBC for 5 days after ella® intake be a secondary endpoint in this 
study. 
 
 
 
G Actual Use:  Proportion of dosing 
instances among user population 
associated with use of hormonal 
contraceptives in the same cycle after 
taking ella® in which subject reports 
using a condom (or other barrier 
method) every time they have sex until 
their next menstrual period. 
Directions: After taking this product; 
users of birth control pills, patch or 
vaginal ring after use of this product: 
Use condoms (or another barrier 
method) every time you have sex until 
your next menstrual period.  
 
 
 
 
Rationale: This secondary endpoint is intended to address the hypothetical risk of 
pregnancy resulting from unprotected intercourse after use of ella® due to the 
potential risk of delayed ovulation in users of hormonal contraceptives. However, 
as described above in Secondary Endpoint F, risk of pregnancy for these women 
is minimal, and therefore this endpoint is also designated a secondary endpoint in 
this AUT. While women who start HBC with a 5-day delay can further decrease 
the slim chance of pregnancy from an act of unprotected sex in that short interval 


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by using condoms, once again, this was a very cautious position since the chance 
of pregnancy in that interval, even without use of a condom, is extremely low. 
Furthermore, all women (not just those starting/restarting HBC after ella® use) 
having unprotected sex after using any method of EC (i.e., ella® or EC containing 
LNG including Plan B) and before their next menses should ideally use condoms 
as back up to reduce the risk of pregnancy, but labeling to that effect is not 
present on other EC products in the OTC marketplace. 
 
 
 
H Actual Use:  Proportion of user 
population who use the study product 
more than once in the same menstrual 
cycle. 
Directions: Do not use more than once 
in the same menstrual cycle. 
 
 
 
 
Rationale: While data has been collected that demonstrates that using ella® more 
than once during a menstrual cycle does not pose any safety risk, the direction not 
to use ella® more than once in a menstrual cycle is still on the prescribing 
information. For this reason, as well as feedback from the FDA, this will therefore 
be tested as a secondary endpoint.  
 
 
 
I 
Self-Selection/Actual Use:  Proportion of 
self-selection population taking one of 
the “ask a doctor or pharmacist before 
use” products who do not select, who 
select but do not use or who report 
contacting a healthcare provider or 
pharmacist 
Consumer Information Leaflet:   
 
Talk to a healthcare professional 
or your pharmacist before taking ella® 
if you are taking certain drugs to treat: 
• 
seizures (barbiturates, 
carbamazepine, felbamate, 
oxcarbazepine, phenytoin, 
topiramate) 
• 
tuberculosis (rifampin) 
• 
fungal infections (griseofulvin) 
• 
HIV or AIDS 
• 
pulmonary hypertension (bosentan) 
• 
St. John’s Wort (or any herbal 
products containing hypericum 
perforatum) 
 
 
 
 
Rationale: In vitro studies indicate that ella® is predominantly metabolized by 
CYP3A4, suggesting that CYP3A4 inducers may decrease the plasma 
concentration of ella® if administered concomitantly, as it was shown with 
rifampicin. However, no clinical studies have demonstrated a potential increased 
risk of pregnancy among women treated with CYP3A4 inducers and there is no 
data indicating that increasing the dose of UPA may have an impact on a 
theoretical risk of pregnancy.  Additionally, similar drug-drug interactions exist for 
levonorgestrel and CYP3A4 inducers, the only other readily available option for 
emergency contraception. 
Unintended pregnancy is particularly undesirable in women taking many of these 
drugs since they are used to treat serious conditions many of which pose 
significant risks to the fetus.  ella® is not contraindicated in these circumstances, 
rather the potential concern is that emergency contraception (including 


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levonorgestrel) may be less effective if used with concomitant medication.  An 
emergency contraceptive which may be slightly less effective is arguably 
preferable to no emergency contraception for this particular group of women. 
Given that the clinical impact of concomitant use of a CYP3A4 inducer with ella® 
use is unclear, that there are no recommendations precluding the use of ella® 
under these circumstances, and that the only other available option for oral EC 
has similar interactions (despite no drug interactions listed in the OTC labeling), 
this endpoint is designated as secondary. 
 
3 
STUDY DESIGN 
This is an observational open-label, multicenter, 6-week study designed to create as 
much as possible an OTC-like environment in which subjects will make a self-selection 
and purchase decision about ella® based only on their reading of the outside of the 
package including the DFL. Qualified subjects who choose to purchase the study 
medication will do so, then leave the study site and use the product on their own. The 
study is designed to assess if, when and how subjects use the medication in an OTC-like 
environment. 
It is important to note that subject characteristics and how they might be related to 
behaviors directed by the DFL that are gathered at screening, enrollment, or during the 
6-week study period will not be discussed directly with subjects until the end of study 
interview. 
3.1 
Naturalistic Design 
This trial is a multi-center trial conducted in a naturalistic environment. Study 
characteristics and procedures were designed to make it as naturalistic as possible. 
Some of the key naturalistic elements include the following: 
• 
There are minimal study exclusionary criteria imposed on subjects, making this 
trial nearly an all-comers study to mimic the likely OTC population. 
• 
The study will be conducted in women’s health clinics and pharmacies, 
representing typical locations where consumers now commonly purchase EC in 
an OTC-like setting. 
• 
The proposed OTC packaging and labeling is the only product information 
provided to subjects during the study. Subjects will only review the outer 
packaging at the initial visit. Study staff will not provide any additional information 
or encouragement regarding product selection at that visit. Staff will not answer 
subject questions but will redirect them to the outer package. 
• 
After purchasing the study product, subjects will take the package with them 
when they leave the site; the package will include the outer packaging and, inside 
the package, the consumer information leaflet (CIL) and study medication. 


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3.2 
Study Sites 
Approximately 25 women’s health clinics and 10 retail pharmacies will be chosen for this 
study as they provide an environment that is considered typical of those from which 
consumers may expect to find this product following approval, and which represent the 
places women currently go to seek EC in an OTC-like setting. The women’s health 
clinics sell currently available OTC EC in an OTC-like manner without the requirement to 
see a clinician. These clinics typically have a window or a front desk area where women 
purchase EC by requesting it from non-clinical staff, in a manner similar to consumers 
purchasing an OTC product in a pharmacy. 
Study sites will be selected to provide geographic and demographic diversity. They will 
be selected from approximately eight geographic regions in the US. Each site has a 
private office or a suitable semi-private area where the study will be carried out privately 
and without distraction. The study area will also have all of the necessary computer 
equipment and a high-speed Internet connection to accommodate the electronic data 
capture system (EDC). 
It is expected that subjects enrolled through health centers are likely to be younger on 
average and have higher prevalence of low literacy than subjects who might respond to 
recruitment for a more typical AUT.  
 Site Training and Procedural Integrity 
PEGUS Research will select sites and train the site staff after approval by the Sponsor 
and the Institutional Review Board (IRB). All study staff will receive study-specific 
training. All training will be documented and retained in the study files. 
3.3 
Subject Selection 
Actual use trials are designed to determine how well the general population of 
consumers is able to apply the information in nonprescription drug labeling to guide their 
own behavior. Subjects should therefore represent a wide range of demographic 
characteristics. 
In order to mimic the OTC marketplace as much as possible, subject selection will be 
self-driven by response to an invitation to participate in the study issued at the point of 
sale for women seeking EC.  In general, that will mean intercepting women who are self-
pay or who are willing to be self-pay for the purposes of the study, and who present for 
EC only. Consumers who are purchasing EC for someone else’s use will not be invited 
to participate, as they cannot give consent on behalf of the actual user. 
Given that adolescents are an important subgroup in the study, adult subjects will be 
constrained to no more than 775 subjects, allowing for an adolescent subgroup number 
of approximately 175. Further, the group of older adolescents (age 15 and older) will be 
constrained to 125, to allow for approximately 50 subjects under the age of 15. If 
adolescent recruitment lags significantly behind adult enrollment, as a backup 
recruitment method, clinicians within the health center will be allowed to invite 
adolescents to participate in the study if the subject identifies a need for EC in the 
context of a clinical visit. In those cases, clinicians will not instruct subjects how to use 


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the study product; they will simply acknowledge the need for EC and extend the 
invitation to participate. 
While it is unusual in an actual use trial to allow for active recruitment on the part of 
clinicians, the FDA-requested goals for adolescent enrollment are very likely to make 
supplemental recruitment measures necessary, particularly for those under age 15. 
Should recruitment via clinicians for adolescent subjects be necessary, in order to 
minimize the potential for bias, clinicians will be trained not to counsel potential 
adolescent subjects about the use of EC in general, nor will they give specific counseling 
about the study product. This supplemental mechanism of recruitment, if used because 
needed to meet adolescent recruitment goals, is unlikely to have any impact on the 
primary endpoints of the study. The usual concern about active clinician recruitment is 
that it may bias self-selection. There are three factors to consider regarding this 
theoretical concern. First, consumers’ ability to self-select for emergency contraception 
as a whole in the OTC market has already been established. Second, self-selection for 
this product is very similar to already available OTC emergency contraceptives. Third, 
any potential bias affecting self-selection would be in the negative direction as subjects 
may indeed select the product mistakenly thinking that the clinician has recommended it, 
when, in fact, the product is not right for them. In order to estimate any impact of clinician 
referral on self-selection endpoints, data will be presented separately for adolescent 
subjects recruited in this manner. 
 Inclusion Criteria: Self-Selection Phase 
In order to enroll a sample as representative as possible of the likely OTC consumer, the 
study inclusion criteria are defined as broadly as it is feasible. Subjects must meet the 
following initial screening inclusion criteria in order to begin the enrollment interview:  
1. Able to read, speak and understand English  
2. Can see well enough to read information on the label  
3. Another member of the respondent’s family has not participated in this study 
4. Consumer or someone else in the household does not work for a market 
research or advertising company, public relations firm, news organization, 
pharmacy or pharmaceutical company, medicine manufacturer, as a healthcare 
professional, or as part of a health care practice, managed care or health 
insurance company, trained or worked as a healthcare professional or market 
research professional (eliminated for reasons of confidentiality and increased 
awareness of medicines and their labels) 
5. Has not participated in a health-related market research or product label study in 
the past 12 months 
6. Has not participated in a clinical trial in the past 12 months 
7. Has never participated in a study about EC 
8. Seeking the use of emergency contraception 


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Additionally, subjects must meet all of the following inclusion criteria to be eligible for 
enrollment into the use phase of the study: 
• 
Evidence of a personally signed and dated informed consent form indicating that 
the subject (or a legal representative) has been informed of all pertinent aspects 
of the study. 
• 
Willing and able to comply with the initial visit and planned phone calls and other 
study procedures. 
 Exclusion Criteria: Use Phase 
All subjects who agree to participate at the site will be asked to make a selection 
decision. Subjects presenting with any of the following will not be included in the use 
phase of the study (i.e., will not be allowed to purchase and use study medication): 
1. Unwilling to purchase study medication. 
2. Unwilling to provide written informed consent. 
3. Unwilling or unable to provide contact information. 
4. Unwilling to state that the product is for their own use and no one else’s. 
5. Pregnant, by self-report or by a urine pregnancy test. 
6. Male. 
7. Known allergy to ulipristal acetate or inactive ingredients. 
8. Currently breastfeeding. 
9. Premenarchal (have not experienced a first menstrual cycle). 
Subject eligibility will be reviewed and documented by the Investigator or his/her 
designee before subjects are allowed to purchase and begin the use phase of the study. 
 Recruitment Methods 
The nature of the indication (emergency contraception) makes recruitment for the trial 
challenging. By definition a woman does not know in advance that she will need EC, and 
when she does need it (because she has had unprotected sex), she needs it quickly. 
Therefore, a passive advertising campaign aimed at consumers interested in the 
indication (the approach typically used in AUTs) is unlikely to be effective for this study. 
Similarly, it would be inappropriate to make a woman who has had unprotected sex and 
is in need of EC as soon as possible wait for a scheduled appointment at the study site 
and potentially delay her taking the EC that she needs to take within a limited timeframe. 
This is particularly true because an approved OTC option is available to her outside the 
study. 
Therefore, subjects will be actively recruited at the point of OTC-like sale in women’s 
health clinics and in the retail pharmacy study sites. Sites which currently sell EC in an 
OTC or OTC-like setting and which have enough EC sales to meet recruitment goals will 
be chosen. They will also be chosen to ensure geographic and demographic diversity, 
and to be as representative of literacy in the general population as possible. When a 
subject presents asking for EC, they will be offered the opportunity to participate in the 


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study. Additionally, posters advertising the study may be placed strategically within the 
sites to attract potential subjects who are there considering a purchase of EC. In the 
event that adolescent recruitment significantly lags behind adult recruitment, as a 
supplementary method of recruitment, clinicians within the health centers will be allowed 
to invite adolescent subjects who, during the course of a clinical visit, have identified the 
need for EC. In those cases, the clinician will be instructed not to give instructions on 
how EC generally or the product specifically is to be used. Potential subjects recruited in 
this way then will be routed to the study staff for the face-to-face enrollment interview. 
See Section 3.3 for more information.  
3.4 
Randomization 
There is no randomization in this study. 
3.5 
Data Collection 
Data will be collected in structured one-on-one interviews using a standardized 
questionnaire either in-person (at the initial enrollment visit) or by telephone (in two 
follow-up interviews). The interviews will be administered by a trained interviewer using 
an internet-based Electronic Data Capture (EDC) application in which the interviewer will 
read the introductory scripts and the questions from the screen and will enter the 
responses directly into the study database. As a precaution, a paper version of the 
questionnaire will be available at each site should there be a loss of internet connection 
while using the EDC system during the course of an interview. This will allow the 
interviewer to complete the enrollment process for that subject; interviews will not be 
started on a paper DCI. Data from any interviews completed on paper will be entered 
into the EDC system as soon as possible after access is restored, and the paper 
questionnaires will be retained as source documents in the study files. 
The questionnaires will include primarily open-ended questions. Question types will 
include direct questions and follow-up questions for clarification. No multiple-choice 
questions will be used. To facilitate the accurate capture of responses, open-ended 
questions will have pre-coded answer alternatives. It is important to note that these 
response alternatives will not be read to the subjects, nor will subjects be able to see 
them on the screen. Where close-ended questions are used (e.g., yes/no, or ok/not ok), 
subjects will be asked to explain their answers so behavior can be adequately assessed. 
When interviewers must type in open-ended question responses, they will capture short 
responses verbatim, and will accurately summarize longer responses.  
During the self-selection interview at the initial visit, the ella® outer package including 
DFL will remain in front of the subject and the subject will be informed they can refer to 
the label at any time. However, the subject will neither be encouraged nor discouraged 
from referring to the package in response to any specific question. 
All data will be collected via standardized, predesigned questionnaires in a one-on-one 
setting either in person or by telephone. For this study, no daily diary will be used. In the 
context of an AUT, a daily diary has the potential to influence subject behavior, making it 
much less naturalistic. In the case of a daily or frequent use medication, the advantages 
of a diary for the purposes of measuring the key endpoints may outweigh those 


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disadvantages. However, in the context of a single use product for EC, subject recall of 
when they took the product relative to unprotected sex and/or enrollment is expected to 
be quite good, as it is a singular, unique event with strong anchoring to context and 
timeline. 
3.6 
Test Materials 
At the initial site visit, subjects will be provided with an empty ella® package that will 
display the proposed DFL (Appendix 18.1); they will review that package/box when 
making a self-selection and purchase decision.  
The product purchased and taken home for use will include the exact same outer 
package, but the study medication and a CIL will be in the package. 
Subjects who enter the use phase will also be provided with an administrative study 
information card (to include subject number, the central telephone number for any 
inquiries and direction to call to report any changes in health [AEs] experienced during 
the study). The administrative study information card will serve as a memory tool for 
subjects, and will not be returned to PEGUS. Subjects will also receive a self-
administered urine pregnancy test to use at the end of the study and a pre-paid envelope 
to mail back unused study product or empty packaging. 
3.7 
Study Administrative Structure 
Laboratoire HRA Pharma is the Sponsor for this study. PEGUS Research is the contract 
research organization (CRO) responsible for the development of the study materials, 
training interviewers, fielding of the study, coding of open-ended responses, analysis of 
the data, and preparation of the study report. 
4 
STUDY TREATMENTS 
4.1 
Allocation to Treatment 
All subjects enrolled in the use phase of this open-label study will be given the 
opportunity to purchase and take 30 mg of ulipristal acetate. 
4.2 
Breaking the Blind 
Not applicable to this study. 
4.3 
Drug Supplies 
 Formulation and Packaging 
Tablets for oral administration contain 30 mg ulipristal acetate and the following inactive 
ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and 
povidone. 
ella® is available as a 30 mg tablet, packaged in a carton containing a blister card with a 
single tablet, constituting one dose. 


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 Preparation and Dispensing 
All subjects who use study medication will take ulipristal acetate 30 mg. Subjects are to 
use the investigational product (IP) based on their understanding of the directions on the 
outer packaging including DFL and inside the product packaging (in the CIL). 
Subjects will be allowed to purchase the study product at the study site. Subjects will not 
be allowed to purchase more than 9 single-count packages during the entire study 
period. They will be allowed to purchase up to 3 packages at a time (on any one 
calendar day) during their first visit to the site and may return to the study site at any 
time to purchase additional medication, up to a total of 9 packages, during the following 
6 weeks. These purchase limits will not be disclosed to subjects unless they try to 
purchase more than 3 packages in a day or more than 9 packages over the course of 
the study. Any such requests that exceed the purchase limits will be recorded. 
It is typical to allow participants in an actual use trial to purchase more IP than they 
would use under usual conditions, in order to allow for the observation and 
measurement of overuse/misuse of the product, should it occur. In this case, as there is 
no true “typical use” for EC because the product is used under unusual circumstances 
(in instances of unprotected sex), purchase limits were chosen to allow for reasonable 
behavior on the part of subjects, even if beyond the label directions, without allowing for 
larger scale misuse. While the expectation is that the vast majority of subjects will 
purchase a single package of the IP, it would be reasonable for subjects to purchase 
additional doses for advance provision. The daily limit was set at three to account for 
this. Again, while the expectation is that very few subjects will return for resupply, in 
order to observe overuse or misuse should it occur, repurchase will be allowed. Indeed, 
given FDA’s expressed concern about the potential for misuse of this product, in 
previous interactions FDA agreed with the planned purchase limits as these limits would 
allow the AUT to estimate the likelihood of potential misuse when the product is 
available OTC. 
 Drug Storage and Accountability 
The Investigator will ensure that the IP is stored under recommended storage conditions 
at the site and in accordance with the drug label (store at controlled room temperature 
20°C to 25°C [68°F to 77°F]; see United States Pharmacopeia [USP]). 
The IP must be stored as indicated on the package. Deviations from the storage 
requirements, including any actions taken, must be documented and reported to the 
monitor by the sites. Deviations outside of the range of 20°C to 25°C [68°F to 77°F], but 
between 15°C and 30°C [59°F and 86°F], will be documented and reported to the 
Sponsor by the monitors and IP will continue to be used. If a deviation is identified 
outside of the range 15°C to 30°C [59°F to 86°F], the deviation must be reported upon 
discovery and the IP must be quarantined and not used until the Sponsor provides 
documentation of permission to use the IP. The Investigator must maintain adequate 
records documenting the receipt, use, loss, or other disposition of the IP(s). 
At the end of the trial, subjects will be asked to return any unused study medication and 
empty packaging. Subjects will be provided with a pre-paid, pre-addressed United States 
Postal Service envelope to send any unused study medication and empty packaging to 


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PEGUS Research. If PEGUS Research has not received the return unused medication 
or empty packaging within three business weeks after the subject exits the study, one 
follow-up telephone call will be placed requesting that the subject return any unused 
study medication and empty packaging. 
The Sponsor will provide instructions as to disposition of any unused and returned IP.  
4.4 
Drug Administration 
Subjects who use the IP are to use it based on their understanding of the labeling. 
Because use of the IP is not driven by protocol, there are no medication errors involving 
subject exposure to the IP, though there may be potential medication errors or uses 
outside of what is foreseen in the protocol that do or do not involve the participating 
subject. Any such medication error will be reported to the HRA pharmacovigilance (PV) 
department. If applicable, any associated adverse event(s) (AE(s)) will be documented 
via the mechanism for spontaneous AE reports. 
 Compliance 
There is no protocol-directed use of the study product and subjects will use the product 
at their own discretion based on their understanding of the DFL and other material on or 
in the package. The subjects will report on their use of the product in the two follow-up 
telephone interview(s). 
4.5 
Concomitant Medication(s) 
The IP packaging (the CIL) will contain information about the use of other medications 
when taking ella®. Subjects will be queried at enrollment about medications that they are 
currently taking. During the two study telephone interviews, subjects will be queried about 
any new medications that they have begun taking since the start of the study. 
4.6 
Rescue/Escape/Salvage Therapy 
Not applicable for this study. 
4.7 
Batch Recall 
In case a batch recall is required during the course of this protocol, site monitors will be 
responsible for communicating with research sites and for organizing and following-up on 
the logistics of the recall, in collaboration with the sponsor and research sites.   
At the end of the process, the site monitors will ensure that the total number of IPs 
returned to the PEGUS matches the total number of IPs delivered to all sites. Any 
discrepancy must be explained. 
5 
STUDY PROCEDURES 
5.1 
Pre-Interview Activities 
Potential subjects who spontaneously present to one of the study sites seeking EC in an 
OTC or OTC-like setting will be invited by clinic or pharmacy staff to participate in the 


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study. Potential subjects who are interested will be immediately routed to study staff 
trained to do the enrollment procedures. 
5.2 
Study Period 
 Enrollment Visit, Self-Selection/Purchase Decision 
At the enrollment/self-selection visit (constituting Study Day 1), which takes places at the 
women’s health clinic or pharmacy, initial inclusion criteria will be reviewed and potential 
subjects will be shown the ella® package and given as much time as needed to review the 
information on the outer package. After reviewing the outer package, they will be asked 
whether the product is okay or not okay for them to use and if they want to purchase the 
product for their own use. Reasons for selection/non-selection and purchase/non-
purchase will be recorded. 
 After Purchase Decision and Before Use Phase 
The purpose of this study is to see how the subject complies with the labeled directions; 
therefore, the date of the use of study medication is determined by the subject. Study Day 
1 will be defined as the day the product is dispensed to the subject. On Study Day 1, 
subjects will complete the enrollment interview including associated medical conditions 
and demographic information. Subjects will also be asked to complete the REALM1 or 
REALM-Teen2 test to establish reading ability. 
Study exclusion criteria will be assessed and only qualified subjects who decide to 
purchase the product will continue on to the study use phase. Subjects will provide 
informed consent. Parental consent and subject assent will be obtained where required 
based on applicable local laws and regulations. See Section 12.3 for further information 
on parental consent of adolescent subjects. 
After consent, all subjects will provide a urine sample for the study staff member to 
conduct a urine-based dip pregnancy test.  Subjects with a positive pregnancy test will be 
asked to make a selection and purchase decision again with the new information 
regarding pregnancy and then excluded from the use phase of the study.  
Qualified subjects will be required to provide contact information (for the purposes of 
conducting telephone follow-up interviews) and information regarding any medications 
they are currently using. Subjects who choose to will then purchase the IP and site study 
staff will complete the electronic product accountability form. While it is expected that 
most subjects will purchase a single package of ella®, subjects will be allowed to 
purchase up to 3 boxes in any one day, and will be allowed to return to the study site at 
any time during the use phase to purchase additional medication. Subjects will not be 
allowed to purchase more than 3 single dose packages in a single day, or more than 9 
single-dose packages during the study period although this will not be communicated to 
the subjects unless they attempt to purchase more than that. Any requests for purchase 
more than the limits will be recorded. 
Subjects will also be informed that study and End-of-Study (EOS) phone interviews will 
be conducted at Week 2/Day 14 (with an allowable window of ±3 days) and at Week 
6/Day 42 (±4 days). Subjects who have purchased the product will be dispensed the 
product to use how and when they see fit. 


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Subjects also will be provided with a self-administered urine pregnancy test and given 
instructions to use the test at the end of the study period. Results will be recorded in the 
database in the End-of-Study interview. 
5.3 
Use Phase 
 Unscheduled Study Site Visits 
During any unscheduled visit to a study site for purposes of subjects obtaining additional 
IP, the study staff contact with the subjects will be limited to: 
1. Dispensing additional IP with no questions asked or answered or directions given 
about the use of the IP by the study staff. 
2. Appropriately documenting the IP dispensed. 
3. Assisting any subject presenting self-reported AEs by immediately having the 
subject contact PEGUS Research. 
 Telephone Interviews 
The two scheduled phone interviews will be conducted by PEGUS Research clinical staff 
(usually nurses) to collect information regarding AEs and concomitant medications. 
During the 6 weeks of the study, subjects will be contacted by phone on Days 14 (with an 
allowable window of ±3 days) and 42 (±4 days) to answer phone interview questions and 
provide information on AEs and concomitant medication (and, in the end of study 
interview, about pregnancy test results). 
In addition, several non-leading questions will be asked about behavior at the two phone 
interviews. Information will be asked for during both phone interviews in a masked 
manner to avoid influencing future behavior (e.g., “Besides taking the medication, is there 
anything else you have done to prevent pregnancy since we last spoke?”). 
Subjects will be compensated for their time and effort to enroll and participate in the study 
at designated intervals during the study. 
5.3.2.1 Week 2 Interview  
The intent of the week 2 interview is to collect information about the initial use of the 
product. Because subjects in this study will be invited to participate after independently 
presenting to the clinic or the pharmacy seeking EC (and not in response to advertising), it 
is expected that most subjects will be purchasing EC for immediate use (because they 
have very recently had an episode of unprotected sex), rather than solely for advanced 
provision. The interview at 2 weeks is intended to ascertain whether the subject took the 
IP, and if so, to collect information about when she took ella® in relation to her enrollment 
visit (and in relation to their most recent episode of unprotected sex) and measure other 
behaviors in the period immediately surrounding taking the product. Timing of this 
interview is expected to be long enough after enrollment to allow for capturing of use 
within or outside of the 5-day window and resumption or starting of hormonal 
contraception use in the 5 or more days after ella® intake, but also to be soon enough that 
recall should not be problematic. Information about AEs and changes to concomitant 
medications will also be collected. 


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5.3.2.2 Week 6 Interview  
Timing of the Week 6 interview is intended to allow for most women to have had at least 
one menstrual period after enrollment. Questions will be designed to collect information 
about behaviors related to EC use outside of the immediate period after use, as well as 
responses to a missed period. Information about AEs and changes to concomitant 
medications will also be collected. 
5.3.2.3 End-of-Study Interview 
In most cases, the EOS interview will take place in conjunction with the 6-week telephone 
call together with the week 6 interview. However, it is conceptualized as a separate 
interview in order to allow for collection of key end of study measures in cases where 
subjects elect to withdraw before the 6-week telephone call. The end-of-study interview 
will collect information from the subject regarding the use of other forms of 
contraception, including other uses of EC (if any) within the study period, and the timing 
of such use. Subjects will also be asked about possible pregnancy, and will be asked to 
report the results of their EOS pregnancy test. This interview allows for direct questions 
about the rationale behind any behaviors that are not consistent with the DFL and CIL, 
without concern about biasing the subject's subsequent behavior. 
5.4 
Subject Withdrawal (Early Termination) 
An EOS interview will be conducted with any subject who discontinues or withdraws 
consent prior to Week 6, unless the subject withdraws consent for disclosure of future 
information. This interview will attempt to collect the EOS information and the reasons for 
the subject’s early termination. If the subject withdraws from the study between days 1 
and 17 (day 14+3), the clinical interviewer will attempt to complete the Week 2 and EOS 
interviews and gather EOS pregnancy test results. If the subject withdraws between days 
17 and 46 (day 42+4), the clinical interviewer will attempt to complete the Week 6 and 
EOS interviews and gather EOS pregnancy test results. See Sections 6.4, 6.5, and 6.6 
for more detailed information on the interviews. 
Subject participation may be terminated by an investigator during the study for any of the 
following reasons: 
• 
Significant protocol violation; 
• 
AEs, including SAEs; 
• 
Pregnancy; 
• 
Physician decision; 
• 
Subject’s request; 
• 
At the discretion of the Investigator or designee if s/he feels that study 
discontinuation is necessary to protect the subject, or that there are 
unmanageable factors that will interfere significantly with the study procedures 
and/or the interpretation of results. 
Any such subjects will be asked to return any unused study medication and empty 
packaging and will be precluded from purchasing additional study medication, but earlier 


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collected data will be used and ongoing data collection will be allowed, unless the subject 
requests otherwise. 
Subjects may withdraw from the trial at any time at their own request, or they may be 
withdrawn at any time at the discretion of the Investigator or Sponsor (or Sponsor 
designee) for safety or behavioral reasons, or the inability of the subject to comply with 
the protocol required schedule of study visits or procedures at a given study site. 
If a subject refuses contact for scheduled follow-up calls, any efforts made to contact the 
subject will be documented. In any circumstance, every effort will be made to document 
subject outcome, if possible. The investigator will inquire about the reason for withdrawal, 
request the subject to return all unused IP(s) and empty packaging, request the subject to 
participate in a final telephone interview, if applicable, and follow up with the subject 
regarding any unresolved adverse events (AEs). 
If the subject withdraws from the study, and also withdraws consent for disclosure of 
future information, no further evaluations will be performed, and no additional data will be 
collected. The Sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
A subject may be declared lost to follow-up if, during the study, the available contact 
information is determined to be incorrect and no other information is available. Every 
attempt will be made to contact lost to follow-up subjects, including three phone call 
attempts and a United States Postal Service (USPS) letter. Subjects whose status is 
withdrawn, lost to follow-up, withdrawal due to an AE or withdrawal from the study for 
other reasons will be recorded in the case report form (CRF). 
If a subject wishes to discontinue his or her participation in the study, the 
Investigator/interviewer will document the reason for withdrawal, ask the EOS questions 
where possible and follow-up with the subject regarding any new or unresolved AEs and 
collect or make arrangements to collect all IP provided to the subject. Data collected up to 
the point of withdrawal will be retained and used as appropriate in the data analysis. 
 
 


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5.5 
Study Flow 
Study procedures are represented in a flow chart in Figure 1 below. 
Figure 1  Study Procedures Flowchart 


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6 
ASSESSMENTS 
Every effort will be made to ensure that the protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time, there may be 
circumstances outside of the control of the Investigator that may make it unfeasible to 
perform the test. In these cases, the Investigator will take all steps necessary to ensure 
the safety and well-being of the subject. When a protocol required test cannot be 
performed, the Investigator will document the reason for this and any corrective and 
preventive actions which he/she has taken to ensure that normal processes are adhered 
to as soon as possible. 
The study team will be informed of these incidents in a timely fashion. All data will be 
collected using an Electronic Data Capture Data Collection Instrument (DCI). 
6.1 
Screening Assessment 
Subjects will be screened during the initial visit to determine those individuals who will be 
included or excluded from the trial.  
6.2 
Enrollment Interview 
Subjects will be shown the ella® outer package and allowed to make a decision about 
whether the product is appropriate for them to use, and whether to purchase ella® for their 
own use. Subsequent questions will be asked to gather limited medical and medication 
history as it pertains to use of the product.  
6.3 
Reading Level Assessment 
The REALM1 (for adults) or the REALM-Teen2 (for adolescents) test will be used to 
measure reading grade level and will be the measure of literacy used for this study. The 
REALM score corresponds to four grade-equivalent reading levels as shown in Table 2 
below, while the REALM-Teen score corresponds to 5 grade-equivalent reading levels as 
shown in Table 3 below. A REALM score of 60 or less (a reading level of 8th grade or 
lower) defines the low literacy subgroup among adult subjects. 
The REALM-Teen test does not have a 9th grade reading level cutoff, so a cutoff score of 
60 or lower will be used to define the low literacy cohort for the adolescent group as well 
(which is the midpoint of the 8th - 9th grade-equivalent reading level). This allows for a 
somewhat more conservative requirement to be classified as low literacy among the 
adolescent cohort in comparison to the cutoff for 10th grade-equivalent reading level. 
The REALM-Teen will be used to demonstrate (along with demographics) that adolescent 
subjects represent a diversity of age, race, educational attainment, and reading ability. 
However, given the relatively small absolute number of low literacy adolescents expected 
(if 25% of the sample of 175 adolescents meet the criteria, this would yield approximately 
44 low-literacy adolescents), low literacy adolescents will be included with low literacy 
adult subjects to comprise the overall low literacy subgroup. 
 
 


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Table 2 REALM Test Grade-Equivalent Reading Levels 
 
REALM1 Score 
Grade-equivalent 
Reading Level 
Included as 
Low-literacy 
Included as 
Normal-literacy 
0-18 
3rd 
X 
 
19-44 
4th to 6th 
X 
 
45-60 
7th to 8th 
X 
 
61-66 
9th and above 
 
X 
Table 3 REALM-Teen Test Grade-Equivalent Reading Levels 
REALM-Teen2 
Score 
Grade-equivalent 
Reading Level 
Included as  
Low-literacy 
Included as  
Normal-literacy 
0-37 
3rd 
X 
 
38-47 
4th - 5th 
X 
 
48-58 
6th - 7th 
X 
 
59-62 
8th - 9th 
≤ 60 
≥ 61 
63-66 
10th and above 
 
X 
 
Given that literacy (as measured by the REALM or REALM-Teen) is not known in 
advance and cannot be directly used in screening in an actual use trial, recruitment 
targets for low literacy are not set. In self-selection and actual use studies that recruit in 
the typical manner, the proportion of low literacy subjects typically ranges from 12-18%. 
In contrast with label comprehension studies, whose samples are meant to be 
approximately representative of the general population and therefore controlling for 
factors of interest like literacy is potentially justified, one of the overarching goals of an 
actual use trial is to enroll a sample based on individuals who present seeking the 
product, and this approximates the likely OTC user population. Actual use trials seek to 
enroll subjects who seek out the product as they are those most likely to use the product 
when available OTC.  In this case, forcing a certain percentage of low-literacy enrollment 
would compromise the representativeness of the sample in a manner that is 
inappropriate. While it is inappropriate to force a specified proportion of low literacy 
subjects in an AUT, it is still important to have a sample of low literacy participants of 
sufficient size to allow for conclusions to be drawn as to performance of study endpoints 
among subjects of low literacy. The total sample size of this study was selected to ensure 
that the absolute size of the subgroup of low literacy participants will be large enough to 
evaluate the endpoints among those of low literacy. If 15% of 950 subjects are classified 
as low literacy by the REALM or REALM-Teen, the cohort of low literacy subjects will be 
approximately 143 subjects, representing a low literary subgroup of sufficient size. As an 
illustration, the 95% confidence interval (exact) around a point estimate of 85% for 143 
subjects is +/-7%. 
6.4 
Interim Follow-Up Telephone Interviews  
During the course of the study, all subjects will be contacted twice via telephone by a 
trained nurse (Interviewer) who will ask a series of questions related to the use of the 
study medication, as well as collect information related to medications and AEs. 


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The answers to these questions will be part of the study database and used to determine 
the performance of the endpoints. There will be a total of 2 phone interviews, one at day 
14 (with an allowable window of ±3 days) and one at day 42±4 days, during which the 
nurses will limit the dialogue with the subjects to the interview script. 
6.5 
End-of-Study/Early Termination Telephone Interview  
The EOS interview will occur at the end of the study (typically this will be in conjunction 
with the 6-week call), or upon early termination from the study. All subjects will be 
contacted via telephone by a trained nurse (Interviewer) who will ask a series of 
questions related to the use of the study medication, as well as collect information related 
to medications and AEs. 
As participation for that subject will then be complete, and therefore the risk of biasing 
future behavior irrelevant, this end-of-study interview will include direct questions about 
how the product was used. The answers to these questions will be part of the study 
database and used to determine the performance of some of the endpoints. 
Typically, the EOS interview will be conducted during the 6-week telephone call 
immediately following the 6-week interim follow-up interview. However, in cases where 
subjects may withdraw earlier for any reason, the EOS interview will be conducted at that 
time. 
6.6 
Pregnancy Testing 
All subjects will be asked directly if they are currently pregnant in the enrollment 
interview. Any subject that reports being pregnant will be disqualified from participation 
in the use phase. Subjects that sign consent will provide a urine sample for the study 
staff member to conduct a urine-based pregnancy test. Subjects with a positive result 
will be informed of the result, asked the selection and purchase question again, and then 
excluded from participating in the use phase. Subjects with a negative result will not be 
provided with the test result, unless they specifically request this information. The 
concern is that a woman who has had recent unprotected sex and seeks EC might 
erroneously interpret a negative pregnancy test as an indication that she does not need 
EC. To minimize this risk, the consent form will contain an explanatory note that 
pregnancy testing cannot detect a pregnancy that may occur as a result of recent 
unprotected sex. At the end of the enrollment interview, subjects who are proceeding 
into the use phase will be given a home pregnancy test (with the instructions to use it) to 
take home and use at the end of the study. Nurse interviewers will inquire about the 
results of the pregnancy test during the EOS interview. An additional call will be placed 
at 7 days ±3 days following the EOS interview to collect that information if the subject 
reported at the EOS interview that they had not yet used the test. This allows for 
shipping time if the subject requires an additional pregnancy test to be sent. In addition, 
at the time a subject withdraws from the study, nurse interviewers will inquire if the 
subject would be willing to take the pregnancy test and report the results. 


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7 
ADVERSE EVENT REPORTING 
7.1 
Adverse Events 
All observed or volunteered AEs regardless of suspected causal relationship to the IP(s) 
will be reported as described in the following sections. This study includes only one 
treatment group. 
While responsibility for collection, recording, and reporting of all AEs will be assumed by 
PEGUS Research, study staff at the study sites will identify any spontaneous reporting of 
AEs to the site staff and facilitate the reporting to the centralized clinical nurse 
interviewers. All site staff and subjects will be provided with a 24-hour toll-free number to 
report any adverse events or other issues. Note that for this section “Investigator” refers 
to the central principal investigator at PEGUS Research who oversees this process.  
For all AEs, the Investigator must pursue and obtain information adequate both to 
determine the outcome of the AE and to assess whether it meets the criteria for 
classification as a serious adverse event (SAE) requiring immediate notification to the 
Sponsor or its designated representative. For all AEs, sufficient information should be 
obtained by the Investigator to determine the causality of the AE. The Investigator is 
required to assess causality. Follow-up by the Investigator may be required until the 
event or its sequelae resolve or stabilize at a level acceptable to the Investigator, and the 
Sponsor concurs with that assessment. 
As part of ongoing safety reviews conducted by the Sponsor, any non-serious AE that is 
determined by the Sponsor to be serious will be reported by the Sponsor as an SAE. To 
assist in the determination of case seriousness further information may be requested 
from the Investigator to provide clarity and understanding of the event in the context of 
the clinical trial. 
7.2 
Reporting Period 
For SAEs, the active reporting period to the Sponsor or its designated representative 
begins from the time that the subject provides informed consent, which is obtained prior 
to the subject’s participation in the use phase of the study, ie, prior to undergoing any 
study-related procedure and/or receiving IP, through and including 28 calendar days after 
the last administration of the IP. SAEs occurring to a subject after the active reporting 
period has ended should be reported to the Sponsor if the Investigator becomes aware of 
them; at a minimum, all SAEs that the Investigator believes have at least a reasonable 
possibility of being related to study drug are to be reported to the Sponsor. 
For non-serious AEs the reporting period begins from the time the subject has taken at 
least 1 dose of study treatment through last subject visit. 
7.3 
Definition of an Adverse Event 
An AE is any untoward medical occurrence in a clinical investigation wherein subjects are 
administered a product or medical device; the event need not necessarily have a causal 
relationship with the treatment or usage. Examples of AEs include but are not limited to: 
• 
Abnormal test findings; 


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• 
Clinically significant symptoms and signs; 
• 
Changes in physical examination findings; 
• 
Hypersensitivity; 
• 
Progression/worsening of underlying disease; 
• 
Drug abuse; 
• 
Drug dependency. 
Additionally, they may include the signs or symptoms resulting from: 
• 
Drug overdose; 
• 
Drug withdrawal; 
• 
Drug misuse; 
• 
Drug interactions; 
• 
Extravasation; 
• 
Exposure during pregnancy; 
• 
Exposure via breastfeeding; 
• 
Medication error; 
• 
Occupational exposure. 
7.4 
Abnormal Test Findings 
The criteria for determining whether an abnormal objective test finding should be reported 
as an AE are as follows: 
• 
Test result is associated with accompanying symptoms, and/or, 
• 
Test result requires additional diagnostic testing or medical/surgical 
intervention, and/or, 
• 
Test result leads to a change in study dosing or discontinuation from the 
study, significant additional concomitant drug treatment, or other 
therapy, and/or, 
• 
Test result is considered to be an AE by the Investigator or Sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does 
not constitute an AE. Any abnormal test result that is determined to be an error does not 
require reporting as an AE. 
7.5 
Serious Adverse Events 
An SAE is any untoward medical occurrence at any dose that: 
• 
Results in death; 
• 
Is life threatening (immediate risk of death); 


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• 
Requires inpatient hospitalization or prolongation of existing hospitalization; 
• 
Results in persistent or significant disability/incapacity (substantial 
disruption of the ability to conduct normal life functions); 
• 
Results in congenital anomaly/birth defect; 
• 
Is a medically important event. 
Medical and scientific judgement is exercised in determining whether an event is an 
important medical event. An important medical event may not be immediately life 
threatening and/or result in death or hospitalization. However, if it is determined that the 
event may jeopardize the subject or may require intervention to prevent one of the other 
AE outcomes, the important medical event should be reported as serious. 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization; or development of drug dependency or drug abuse. 
 Protocol-Specified Serious Adverse Events 
There are no protocol-specified SAEs in this study. All SAEs will be reported by the 
investigator as described in previous sections, and will be handled as SAEs in the safety 
database (see Section on SAE Reporting Requirements). 
7.6 
Hospitalization 
AEs reported from studies associated with hospitalization or prolongations of 
hospitalization are considered serious. Any initial admission (even if less than 24 hours) 
to a healthcare facility meets these criteria. Admission also includes transfer within the 
hospital to an acute/intensive care unit (e.g., from the psychiatric wing to a medical floor, 
medical floor to a coronary care unit, neurological floor to a tuberculosis unit). 
Hospitalization does not include the following: 
• 
Rehabilitation facilities; 
• 
Hospice facilities; 
• 
Respite care (e.g., caregiver relief); 
• 
Skilled nursing facilities; 
• 
Nursing homes; 
• 
Routine emergency room admissions; 
• 
Same day surgeries (as outpatient/same day/ambulatory procedures). 
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical 
AE is not in itself an SAE. Examples include: 
• 
Admission for treatment of a preexisting condition not associated with the 
development of a new AE or with a worsening of the preexisting 
condition (e.g., for work-up of persistent pre-treatment lab abnormality); 
• 
Social admission (e.g., subject has no place to sleep); 


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• 
Administrative admission (e.g., for yearly physical exam); 
• 
Protocol specified admission during a study (e.g., for a procedure 
required by the study protocol); 
• 
Optional admission not associated with a precipitating clinical AE 
(e.g., for elective cosmetic surgery); 
• 
Hospitalization for observation without a medical AE; 
• 
Pre-planned treatments or surgical procedures should be noted in the 
baseline documentation for the entire protocol and/or for the individual 
subject 
Diagnostic and therapeutic non-invasive and invasive procedures, such as surgery, 
should not be reported as AEs. However, the medical condition for which the procedure 
was performed should be reported if it meets the definition of an AE. For example, an 
acute appendicitis that begins during the AE reporting period should be reported as the 
AE and the resulting appendectomy should be recorded as treatment of the AE. 
7.7 
Severity Assessment 
If required on the AE CRFs, the Investigator will use the adjectives MILD, MODERATE, 
or SEVERE to describe the maximum intensity of the AE. For purposes of consistency, 
these intensity grades are defined as follows: 
MILD 
Does not interfere with subject's usual function. 
MODERATE 
Interferes to some extent with subject's usual function. 
SEVERE 
Interferes significantly with subject's usual function. 
Note the distinction between the severity and the seriousness of an AE. A severe event is 
not necessarily an SAE. For example, a headache may be severe (interferes significantly 
with subject's usual function) but would not be classified as serious unless it met one of 
the criteria for SAEs, listed above. 
7.8 
Causality Assessment 
The Investigator’s assessment of causality must be provided for all AEs (serious and non- 
serious). The Investigator must record the causal relationship in the CRF, as appropriate, 
and report such an assessment in accordance with the serious adverse reporting 
requirements if applicable. An Investigator’s causality assessment is the determination of 
whether there exists a reasonable possibility that the investigational product caused or 
contributed to an AE; generally, the facts (evidence) or arguments to suggest a causal 
relationship should be provided. If the Investigator does not know whether or not 
investigational product caused the event, then the event will be handled as “related to 
investigational product” for reporting purposes, as defined by the Sponsor. If the 
Investigator's causality assessment is "unknown but not related to investigational 
product", this should be clearly documented on study records. 
In addition, if the Investigator determines an SAE is associated with study procedures, 
the Investigator must record this causal relationship in the source documents and CRF, 


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as appropriate, and report such an assessment in accordance with the SAE reporting 
requirements, if applicable. 
7.9 
Exposure During Pregnancy 
For IPs and for marketed products, an exposure during pregnancy (EDP) occurs if: 
• 
A female becomes, or is found to be, pregnant either while receiving or being 
exposed (e.g., due to treatment or environmental exposure) or after 
discontinuing or having been directly exposed to the IP; 
• 
A male has been exposed (e.g., due to treatment or environmental exposure) to 
the IP prior to or around the time of conception or is exposed during his partner’s 
pregnancy. 
If a study subject becomes or is found to be pregnant during the study subject’s treatment 
with the IP, the Investigator must submit this information to the Sponsor as an EDP, 
regardless of whether an SAE has occurred. The information submitted should include 
the anticipated date of delivery (see below for information related to termination of 
pregnancy). 
Follow-up is conducted to obtain pregnancy outcome information for all pregnancy 
reports with an unknown outcome. The Investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify the Sponsor of the outcome as a 
follow up to the initial pregnancy report. In the case of a live birth, the structural integrity 
of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
pre-procedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
If the outcome of the pregnancy meets the criteria for an SAE (i.e. ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly 
[in a live born, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
Investigator should follow the procedures for reporting SAEs. 
Additional information about pregnancy outcomes that are reported as SAEs follows: 
• 
Spontaneous abortion includes miscarriage and missed abortion. 
Neonatal deaths that occur within 1 month of birth should be reported, without regard to 
causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs 
when the Investigator assesses the infant death as related or possibly related to 
exposure to IP. 
Additional information regarding the EDP may be requested by the Investigator. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (e.g., follow-up on 
preterm infants to identify developmental delays). 


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7.10 Withdrawal Due to Adverse Events 
Withdrawal due to AE should be distinguished from withdrawal due to insufficient 
response, according to the definition of AE noted earlier, and recorded on the appropriate 
AE CRF page. 
When a subject withdraws due to an SAE, the SAE must be reported in accordance with 
the reporting requirements defined herein. 
7.11 Eliciting Adverse Event Information 
The Investigator is to report all directly observed AEs and all AEs spontaneously reported 
by the study subject. In addition, each study subject will be questioned about AEs during 
all phone interviews. 
7.12 Reporting Requirements 
Each AE is to be assessed to determine if it meets the criteria for SAEs. If an SAE 
occurs, expedited reporting will follow local and international regulations, as appropriate. 
 Serious Adverse Event Reporting Requirements 
If an SAE occurs, the Sponsor is to be notified within 24 hours of study staff awareness of 
the event. In case of SAE, the investigator must immediately complete the SAE data 
collection form and send it by fax or by email within 24 hours to the Sponsor’s 
Pharmacovigilance Department: 
Fax: +33 1 42 77 03 52 
Email: pharmacovigilance@hra-pharma.com 
 
In particular, if the SAE is fatal or life-threatening, notification to the Sponsor must be 
made immediately, irrespective of the extent of available AE information. This time frame 
also applies to additional new information (follow-up) on previously forwarded SAE 
reports as well as to the initial and follow-up reporting of exposure during pregnancy. 
In the rare event that the Investigator does not become aware of the occurrence of an 
SAE immediately (e.g., if an outpatient study subject initially seeks treatment elsewhere), 
the Investigator is to report the event within 24 hours after learning of it and document the 
time of his/her first awareness of the AE. 
For all SAEs, the Investigator is obligated to pursue and provide information to the 
Sponsor in accordance with the time frames for reporting specified above. In addition, an 
Investigator may be requested by the Sponsor to obtain specific additional follow-up 
information in an expedited fashion. This information collected for SAEs is more detailed 
than that captured on the AE CRF. In general, this will include a description of the AE in 
sufficient detail to allow for a complete medical assessment of the case and independent 
determination of possible causality. Information on other possible causes of the event, 
such as concomitant medications and illnesses must be provided. In the case of a subject 
death, a summary of available autopsy findings must be submitted as soon as possible to 
the Sponsor or its designated representative. 


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 Non-Serious Adverse Event Reporting Requirements 
All AEs will be reported on the AE page(s) of the CRF. It should be noted that the form for 
collection of SAE information is not the same as the AE CRF. Where the same data are 
collected, the forms must be completed in a consistent manner. For example, the same 
AE term should be used on both forms. AEs should be reported using concise medical 
terminology on the CRFs as well as on the form for collection of SAE information. 
 Sponsor Reporting Requirements to Regulatory Authorities 
Adverse event reporting to regulatory authorities, including suspected unexpected serious 
adverse reactions (SUSAR) is the responsibility of the Sponsor PV department and will 
be carried out in accordance with applicable local regulations by the Sponsor. 
8 
DATA MANAGEMENT 
8.1 
EDC System 
Information collected during the subject interviews will be entered directly into an EDC 
application (DATATRAK ONE, DATATRAK International, Inc.). Automatic data checks 
will alert users of discrepancies and inconsistencies, where applicable. In the event of a 
data entry error, users will have the ability to correct information previously entered. Data 
Management will review the information entered as defined in this protocol.  
All users will have a unique login user name and password, and system access 
privileges will be strictly controlled and documented. Whenever data is modified after the 
initial data entry process, a computer-generated audit trail entry will be created. The 
audit trail, user access privilege processes, and electronic signatures collected by the 
system will be compliant with 21 CFR Part 11 requirements.  
If an internet connection is not available, the interview will not be started. If the internet 
connection is lost during the course of an interview, a paper copy of the electronic forms 
will be available to complete the interview. When the Internet connection is restored, 
study staff at the site will enter the data from the paper forms into the EDC system. If this 
were to occur, the completed paper copy of the electronic forms is the source document. 
Otherwise, the electronic record is the source. 
8.2 
Data Management Plan 
A detailed Data Management Plan (DMP) will describe procedures to ensure the proper 
management and quality of study data and additional PEGUS Standard Operating 
Procedures (SOPs) specify the activities performed to ensure the quality, accuracy and 
reliability of the statistical analysis and the final study report.  
8.3 
Conceptual Approach to Self-Selection 
This is not a dedicated self-selection study, however every AUT has some component of 
self-selection, and, in fact, one of the secondary endpoints in this study is the typical 
self-selection metric. 
Conceptually, the self-selection decision can be characterized as a 2x2 table (Table 4 
below) where the subject's decision to select or not select the study product for use is 


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crossed with whether or not it is appropriate for subject to use, based on subject's self-
reported health status and clinical characteristics. 
Table 4 Self-Selection Decision Outcomes 
Subject’s 
Selection Decision 
Appropriate to Use 
YES 
NO 
YES (selectors) 
Cell A 
Correct Decision 
Cell B 
Incorrect Decision 
NO (non-selectors) 
Cell C 
Incorrect Decision 
Cell D 
Correct Decision 
 
The four cells in the self-selection matrix can be characterized as follows.  
Cell A: Subjects who say the study product is right for them to use and based on 
their self-reported medical and demographic information, the study product is 
right for them to use.  
Cell B: Subjects who say the study product is right for them to use and based on 
their self-reported medical and demographic information, the study product is not 
right for them to use.  
Cell C: Subjects who say the study product is not right for them to use and based 
on their self-reported medical and demographic information, the study product is 
right for them to use.  
Cell D: Subjects who say the study product is not right for them to use and based 
on their self-reported medical and demographic information, the study product is 
not right for them to use. 
8.4 
Classification Activities 
In order to evaluate subjects for the relevant endpoints, each subject will be classified on 
two key variables: (1) the selection decision and (2) the appropriateness of use given the 
selection decision, in order to populate the typical 2x2 self-selection table (Table 4 
above). Subjects will be classified on these two variables as described in Sections 8.4.1 
and 8.4.2 below. 
 Selection Decision 
The selection phase of the interview consists of the self-selection question and the 
purchase question, with accompanying neutral follow-up questions. All subjects who go 
on to actually purchase the study product will be categorized as selectors. Even subjects 
who do not eventually complete the purchase of the product will be classified as a 
selector or a non-selector on the basis of the initial selection and purchase questions. 
However, all information recorded during the selection phase of the interview will be 
considered in the classification of subjects as selectors or non-selectors. Subjects who 
offer modifying information in open-ended responses to neutral probing will be re-


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categorized accordingly. Please note that for this study, subjects are offered the 
opportunity to enroll when they present for purchase of EC. That is, these are subjects 
who came to the site having already determined they need EC and expecting to 
purchase EC.  
A subject who initially indicates that they would select and purchase the product, but 
who independently and unprompted changes their purchase decision during the 
selection phase of the interview would be categorized as a non-selector. For the majority 
of subjects, any information offered once the interview proceeds beyond the selection 
phase of the interview will not be considered during selection classification. However, for 
subjects that self-report not being pregnant, sign consent and then receive a positive 
result from the enrollment pregnancy test, the selection questions will be asked again 
and used to classify the subject as a selector or non-selector. Financial and cost-related 
reasons for saying no to the purchase question will not be used as rationale for re-
classifying subjects who would otherwise be selectors.   
The selection decision for each subject will be examined on a case-by-case basis, taking 
into account all the information gathered during the selection phase of the interview. Two 
independent coders will evaluate the available data and indicate whether the subject is a 
selector or a non-selector. Discrepancies will be resolved by a third coder (as described 
in Section 8.4.3). 
 Appropriate to Use 
Non-selectors will be classified on the variable Appropriate for Use as follows: 
Yes: meets the label criteria for use, representing those who could have 
selected appropriately, but did not (Cell C). 
No: does not meet the label requirements for use, and appropriately did not 
select (Cell D). This includes those subjects who otherwise might have met 
the strict criteria for appropriate use according to the DFL, but who give a 
medically appropriate rationale for their non-selection decision. For example, 
if a subject who otherwise meets the labeled criteria for use does not select 
the product and for example cites the desire to use another EC product so 
they can restart hormonal contraception immediately as their reason for not 
selecting, that subject will be re-classified from Cell C to Cell D. A physician 
will review the casebook for each subject who falls into Cell C to determine if 
any subjects meet that criterion. 
Selectors will be classified on the variable Appropriate for Use as follows: 
Yes: either meets the strict label criteria for use (1-Correct Selectors) or 
reported and measured characteristics justify the selection decision (2-
Acceptable Selectors), representing those who chose to use the product who 
made a clinically acceptable decision despite not meeting the strict label 
criteria for use (Cell A). 
No: does not meet strict label criteria and reported and measured 
characteristics do not justify the selection decision (3-Incorrect Selectors), 
representing those who chose to use the product, but should not have (Cell 
B). 
Complete definitions of Correct, Acceptable, and Incorrect Selectors follow: 


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1) Correct Selectors. Subject meets the strict criteria of the Drug Facts label, 
including: 
a) No contraindications (not pregnant or breastfeeding, no known allergy 
to any of the ingredients, no previous use of ella® within the same 
menstrual cycle, no use as regular birth control) 
b) Is a woman of childbearing potential. This would include all women 
who do not report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
c) Has had unprotected sex in the 5 days prior to use of the product  
2) Acceptable Selectors. Subject does not meet the strict criteria of the DFL, 
but selection is classified as appropriate because they are judged 
clinically (see Section 8.4.3) to be an appropriate selector. This group is 
expected to be quite small. 
3) Incorrect Selectors. This group includes selectors who are not correct or 
acceptable, including having any of the following: 
a) A contraindication to the product (are pregnant or breastfeeding, or 
has an allergy to one of the ingredients, previously used ella® within 
the same menstrual cycle, or use as regular birth control) 
b) Is a man 
c) Is a woman without childbearing potential. This would include all 
women who report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
d) Has not had unprotected sex in the 5 days prior to use of the product 
Please note, for the purposes of this study, for all subjects who qualify to purchase the 
product, self-selection will be evaluated at the time of use, rather than time of purchase, 
and each instance of use will be independently evaluated for the self-selection 
endpoints. For example, if a subject purchases two packages of the study product, using 
one immediately and one four weeks later, each of those use instances will be evaluated 
for appropriateness. Because the timing of the most recent episode of unprotected sex is 
one of the elements of appropriate use, behavior surrounding each dosing instance must 
be the basis for self-selection evaluation. 
Subjects who are either pregnant or breastfeeding and who select the product will be 
precluded from purchasing, and will be classified as incorrect selectors. 
 Physician Mitigation 
Subjects occasionally make a decision to select a product for use that according to the 
strict DFL-defined algorithm appears to be an incorrect decision, but, when examined 
clinically, is acceptable. This review and clinical judgement will be done by three 
physicians working independently, evaluating the entire casebook for each Incorrect 
Selector (as defined above in Section 8.4.2) for evidence that the subject made a 
clinically justifiable selection decision. Their assessments are then compared, and any 
discrepancies resolved by a majority rule. 


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Each physician reviewer will review the entire casebook for every subject who falls into 
Cells B or C of the self-selection table. For subjects in Cell B, physicians will make an 
assessment of whether the use instance was acceptable based on clinical judgement of 
the subject’s behavior and her stated reasons for those actions. If yes, each physician’s 
complete rationale for mitigation will be recorded and the subject will be reclassified from 
Cell B to Cell A. For subjects in Cell C, physicians will make an assessment of whether 
the non-selection decision was based on a reasonable medical rationale. If yes, each 
physician’s complete rationale for mitigation will be recorded and the subject will be 
reclassified from Cell C to Cell D. 
 Coding of Open-ended Responses 
The responses to open-ended questions will be coded to make them amenable to 
numeric analysis and display. Coding procedures will follow PEGUS Research SOP 
DAT:008. Once data for at least 50% of subjects has been collected, listings of individual 
responses for each question will be created. The listings will be reviewed to discover the 
underlying conceptual structure suggested by the data, and a coding frame (a list of 
categories, each of which is assigned a one or two-digit number) will be created for each 
question. The coding frames will be reviewed and revised as necessary when 100% of 
the data is collected and cleaned. When the coding frame is finalized, reviewed and 
approved, coding may be performed.  
Coding will be done using data from the final, clean data set. Two coders working 
independently will code each question with a significant number of responses (e.g. >25). 
Their code assignments will then be compared and the Coding Supervisor will resolve 
any discrepancies. Multiple codes (typically no more than seven) may be assigned to 
elements of one response. Once coded, these data will be displayed in standard 
frequency tables. For these tables, the unit of analysis, and thus the denominator, 
changes to become the number of responses rather than the number of subjects. 
9 
DATA ANALYSIS/STATISTICAL METHODS 
A detailed methodology for the statistical analyses of the data collected in this study will 
be documented in a Statistical Analysis Plan (SAP), which will be finalized prior to 
database lock. The SAP may modify the plans outlined in the protocol; however, any 
major modifications to the primary endpoint definition and/or its analysis will also be 
reflected in a protocol amendment. 
This is a naturalistic, observational trial to assess use patterns from the prospective OTC 
population in a simulated OTC setting. The analyses will largely employ descriptive 
statistics including frequencies, percentages and appropriate summary statistics. 
9.1 
Sample Size Determination 
For the purposes of this AUT, sample size has been set for practical and logistical 
reasons at approximately 950 purchasers. Given that subjects are recruited after 
independently seeking EC, most of those who enter the self-selection phase are 
expected to purchase, and most purchasers are expected to actually use the product 
during the study. If approximately 75% of subjects pass the screening criteria, self-select 


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and both qualify and agree to purchase and enter the use phase, it is expected that up to 
1270 subjects will need to be interviewed to yield 950 purchasers. 
Assuming approximately 950 purchasers, if 80% of those purchasers use the product 
within the study period, that would yield a user population of 760. Estimating 
approximately 40% of users will have had recent hormonal contraceptive use would yield 
a recent hormonal contraceptive users population of 305. Allowing for a further 20% loss 
to follow-up yields a user population of approximately 608 and a recent hormonal 
contraceptive user population of 245. 
Because actual use trials are not hypothesis-testing comparative trials, study sample 
size is designed to allow for adequate evaluation of key endpoints across all subjects 
and among several subgroups. As the analysis of actual use trials typically focuses on 
estimating the proportion (and associated 95% confidence intervals) of individual 
endpoints, sample size is most often based on the number of subjects needed to 
constrain the confidence interval (CI) to a limited range. For this study, assuming 85% 
correct response (the confidence interval depends on the actual point estimate), a 
sample of 608 subjects would constrain the CI to ±3.1%. For purposes of illustration, 
Table 5 provides the 2-sided exact 95% confidence interval for various sample sizes 
around a point estimate of 85%. 
Table 5  Two-sided 95% CIs for Various Sample Sizes Around 85% Point Estimate 
 
N=760a 
N=608b 
N=245c 
N=143d 
95% CI around a point estimate of 85% 
±2.7% 
±3.1% 
±5.1% 
±7.0% 
a User population (maximum) 
b User population (allowing for loss-to-follow up) 
c Recent hormonal contraceptive users 
d Low literacy subjects 
 
9.2 
Analysis Populations 
The populations of interests are defined as follows: 
• 
Responder Population:  Subjects who accept the invitation to participate and 
begin the screening process (including those who do not meet screening 
criteria for proceeding to the self-selection phase). 
• 
Self-Selection Population:  Subjects who accept the invitation to participate 
and meet study inclusion criteria, participate in a face-to-face interview at 
the study site and make a self-selection and purchase decision. 
• 
Purchasers:  Subjects who meet study enrollment criteria and purchase the 
study medication. 
• 
User Population:  Subjects who take at least one dose of study medication 
during the study.  
• 
Recent hormonal contraceptive users:  Subjects in the user population who also 
report recent hormonal contraceptive use (i.e., use of a hormonal contraceptive 
within the previous two months). 


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9.3 
Endpoint Analysis 
A summary of the disposition of subjects (including responders, self-selection 
population, purchasers and users) and reasons for exclusion from these populations 
will be provided. Demographic characteristics, medical history and other background 
information will be summarized for the responder, self-selection, purchaser, and user 
populations. 
Frequencies and percentages will be presented for categorical data, mean, standard 
deviation (SD); median, and range will be presented for numerical data. 
Frequencies, percentages and 2-sided 95% CI will be calculated for the primary and 
secondary endpoints using the exact method. For the primary endpoints, it will be 
concluded that the established target threshold is reached if the lower limit of the CI of 
the point estimate is equal to or exceeds the value of the pre-determined threshold.  
Several of the endpoints are based on dosing instance, rather than by subject, as 
subjects have the potential to take more than one dose over the course of the study.  
Correctness of selection or behavior can only be evaluated at the time of use, rather 
than at the time of purchase.  However, for each of those endpoints a secondary 
analysis by subject will also be presented. 
Endpoints and demographics will be presented for subgroups of interest, with subjects 
dichotomized on the corresponding variables, which include (but are not necessarily 
limited to) literacy, gender, age (adolescent vs. adult women), and history of HBC use. 
A more detailed description of planned data analysis procedures will be found in the 
SAP which will be approved and signed before the database is locked. 
 Primary Endpoint Analysis 
Frequencies, percentages and two-sided exact 95% confidence intervals will be 
calculated for the three primary endpoints for the entire study population and for selected 
subgroups. 
9.3.1.1 A:  Actual Use:  Proportion of dosing instances among user population taken 
within 120 hours (5 days) of most recent episode of unprotected sex. 
The first primary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP and the numerator includes all dosing instances of the IP which were 
taken within 120 hours (5 days) of the subject’s most recent episode of unprotected sex. 
9.3.1.2 B:  Actual Use:  Proportion of dosing instances among user population in which 
no more than one tablet was taken. 
The second primary endpoint is the proportion in which the denominator is all discrete 
dosing instances of the IP and the numerator includes all dosing instances where no 
more than one tablet was taken. 


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9.3.1.3 C:  Self-Selection:  Proportion of female selectors who are not pregnant at the 
time of selection decision. 
The third primary endpoint is the proportion in which the denominator includes all 
females who selected to use the product (regardless of whether they purchased/used) 
and the numerator includes all female selectors who were not pregnant at the time of the 
selection decision. In the case of subjects that report not being pregnant, sign consent 
and then receive a positive result on the pregnancy test, the second selection decision 
will be used for analysis of this endpoint. 
 Target Thresholds 
The threshold for the three primary endpoints is 90%. The objective will be considered 
met for these endpoints if the lower bound of the 2-sided 95% CI for each endpoint 
meets or exceeds the established threshold. 
• 
A:  Actual use: Proportion of dosing instances among user population taken 
within 120 hours (5 days) of most recent episode of unprotected sex. 
The Sponsor proposes to test this message as a primary endpoint because it 
communicates directions for effective use of ella®, and the limited time-window for its 
effective use. Use of ella® after 5 days diminishes or abolishes the product’s efficacy, 
although it is not expected to introduce any drug-related risks. Despite the fact that this 
label language is almost identical to the label language tested, approved, and in-market 
for Plan B One-Step (PBOS) (which is “Take as soon as possible and no later than 3 
days (72 hours) after unprotected sex”), the Sponsor will test this as a primary endpoint. 
Testing it as a primary endpoint would test whether the longer time window (5 vs 3 days) 
during which consumers may benefit from ella® use is well-followed. This would also 
allow us to confirm that consumers do not take ella® later after unprotected intercourse 
than recommended in the product label. 
A performance threshold of 90% is proposed because while taking the product within the 
5-day window is very important to maximize effectiveness, taking it outside of the 5 days 
window is not expected to introduce any serious drug-related risks. 
• 
B:  Actual Use:  Proportion of dosing instances among user population in which 
no more than one tablet was taken. 
The Sponsor proposes to test this message as a primary endpoint in the context of 
FDA’s recommendation to demonstrate in an AUT whether consumers misuse ella® and 
one of the potential misuse scenarios would be the intake of more than the 
recommended dose, which would be assessed through this endpoint.  
A threshold of 90% was designated despite the fact that dose-finding studies using up to 
200 mg of UPA (more than 6 times the intended 30 mg dose) demonstrated no safety 
concerns (HRA2914-503). Accordingly, it is likely that taking more than the 
recommended dose is likely to impose little or no additional risk in women. 


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• 
C:  Self-Selection:  Proportion of female selectors who are not pregnant at the 
time of selection decision.  
The Sponsor proposes to test this message as a primary endpoint as it would allow the 
study to confirm that consumers do not select ella® if they know they are already 
pregnant. 
Of important note, the caution against use if already pregnant is on the approved and 
marketed PBOS DFL that uses the exact same language as that proposed on the ella® 
DFL (“Do not use if you are already pregnant (because it will not work)”. The ella® LCS 
demonstrated that consumers understand this warning extremely well. Moreover, data 
suggest use of ella® in pregnancy is safe. For ella®, the analysis of the global pregnancy 
safety database conducted in the context of the Ellipse II study has been specifically 
intended to assess the occurrence rates of outcomes of pregnancies exposed to ella® 
due either to failure of the EC or inadvertent exposure during pregnancy, including fetal 
and neonatal outcomes and maternal pregnancy complications. Data from the collected 
UPA-exposed pregnancies did not reveal a negative signal on the course of the 
pregnancy, its outcome, or the growth and development of the embryo and the fetus. 
Despite the fact that the available safety data are reassuring were a pregnant woman to 
take ella®, this has been designated as a primary endpoint in this AUT with a 90% 
threshold. 
 Secondary Endpoint Analysis 
9.3.3.1 D:  Self-Selection:  Proportion of female selectors who are not breastfeeding at 
the time of selection decision. 
The first secondary endpoint is the proportion in which the denominator includes all 
females who selected to use the product (regardless of whether they purchased/used) 
and the numerator includes all female selectors who were not breastfeeding at the time 
of the selection decision. 
9.3.3.2 E:  Self-Selection:  Proportion of self-selection population who make a correct 
selection decision regarding use of the product. 
This endpoint is the proportion of those subjects making the self-selection decision who 
make a correct decision about whether the product is right for them to use, as outlined 
below. 
9.3.3.2.1 Populating the Self-Selection Table 
Each subject will be classified on two key variables: (1) the selection decision and (2) the 
appropriateness of use given the selection decision, in order to populate the typical 2x2 
self-selection table. 
Selection Decision:  The selection phase of the interview consists of the self-selection 
and purchase questions, with accompanying neutral follow-up questions. All subjects 
who go on to actually purchase the study product will be categorized as selectors. Even 


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subjects who do not eventually complete the purchase of the product will be classified as 
a selector or a non-selector primarily on the basis of the initial self-selection and 
purchase questions, or in the case of a positive enrollment pregnancy result, the second 
self-selection and purchase question. However, all information recorded during the 
selection phase of the interview will be considered in the classification of subjects as 
selectors or non-selectors. Subjects who offer modifying information in open-ended 
responses to neutral probing will be re-categorized accordingly. 
 
Appropriate to Use:   
Non-selectors will be classified on the variable Appropriate for Use as follows: 
Yes: meets the label criteria for use, representing those who could have 
selected appropriately, but did not (Cell C). 
No: does not meet the label requirements for use, and appropriately did not 
select (Cell D). This includes those subjects who otherwise might have met 
the strict criteria for appropriate use according to the DFL, but who give a 
medically appropriate rationale for their non-selection decision. For example, 
if a subject who otherwise meets the labeled criteria for use does not select 
the product and cites the fact that they are taking a medicine for Human 
Immunodeficiency Virus (HIV) as their reason for not selecting (which 
otherwise does not disqualify a subject from using, but rather suggests that 
they talk to a doctor), that subject will be re-classified from Cell C to Cell D. A 
physician will review the casebook for each subject who falls into Cell C to 
determine if any subjects meet that criterion. 
Selectors will be classified on the variable Appropriate for Use as follows: 
Yes: either meets the strict label criteria for use (1-Correct Selectors) or 
reported and measured characteristics justify the selection decision (2-
Acceptable Selectors), representing those who chose to use the product who 
made a clinically acceptable decision despite not meeting the strict label 
criteria for use (Cell A). 
No: does not meet strict label criteria and reported and measured 
characteristics do not justify the selection decision (3-Incorrect Selectors), 
representing those who chose to use the product, but should not have (Cell 
B). 
Complete definitions of Correct, Acceptable, and Incorrect Selectors follow: 
4) Correct Selectors. Subject meets the strict criteria of the Drug Facts label, 
including: 
a) No contraindications (not pregnant or breastfeeding, no known allergy 
to any of the ingredients, no previous use of ella® within the same 
menstrual cycle, no use as regular birth control) 
b) Is a woman of childbearing potential. This would include all women 
who do not report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
c) Has had unprotected sex in the 5 days prior to use of the product  


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5) Acceptable Selectors. Subject does not meet the strict criteria of the Drug 
Facts label, but selection is classified as appropriate because they are 
judged clinically (see Section 8.4.3) to be an appropriate selector. This 
group is expected to be quite small. 
6) Incorrect Selectors. This group includes selectors who are not correct or 
acceptable, including having any of the following: 
a) A contraindication to the product (are pregnant or breastfeeding, has 
an allergy to one of the ingredients, previously used ella® within the 
same menstrual cycle, or use as regular birth control) 
b) Is a man 
c) Is a woman without childbearing potential. This would include all 
women who report any of the following:  surgical sterilization (tubal 
ligation, hysterectomy, or bilateral oophorectomy) or postmenopausal 
for at least one year 
d) Has not had unprotected sex in the 5 days prior to use of the product 
 
9.3.3.2.2 Analyzing the Self-Selection Table 
Cell A represents a correct decision, namely consumers for whom the study product is 
right to use who choose to use it, and therefore presents very little potential adverse 
clinical consequences.  
Cell C, while not technically correct, is a decision that accrues no health risk, but rather 
is a missed opportunity to use the drug. Thus, these subjects are considered neither 
correct nor incorrect and are usually left out of the primary self-selection analysis. 
The most critical self-selection decision is made by subjects who, based on their health 
status, should not use the study drug (cells B and D). Unlike an incorrect decision by 
consumers for whom this product is appropriate (cell C), an incorrect decision (cell B) by 
these consumers has potential efficacy or safety implications. 
Because it is expected that very few subjects will be inappropriate for use, this endpoint 
will be measured by the following proportion, taken from the self-selection table [(cell A + 
cell D)/(cell A + cell B + cell D)]. Again, note that this does not take into account cell C, 
as those subjects could have chosen to use the product, but did not (for whatever 
reason). 
Other proportions will also be presented, including the total correct selectors as 
described by the equation [(cell A + cell D) / (cell A + cell B + cell C + cell D)] and the 
typical self-selection metric, namely the proportion described by the equation [cell D/(cell 
B + cell D)]. This proportion represents a correct non-selection decision. In other words, 
this is the proportion of those who should not select the product who correctly do not 
select it. 


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9.3.3.3 F:  Actual Use:  Proportion of dosing instances among user population in which 
HBC is not taken for 5 days after taking ella® 
This secondary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP and the numerator includes all dosing instances in which there is no 
reported use of HBC for at least 5 days. 
9.3.3.4 G:  Actual Use:  Proportion of dosing instances among user population 
associated with use of hormonal contraceptives in the same cycle after taking 
ella® in which subject reports using a condom (or other barrier method) every 
time they have sex until their next menstrual period. 
This secondary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP among those who start or restart hormonal contraception in the same 
menstrual cycle and the numerator includes dosing instances where the subject reports 
using condoms every time they have sex during the remainder of that menstrual period. 
9.3.3.5 H:  Actual Use:  Proportion of user population who do not use the study product 
more than once in the same menstrual cycle. 
This secondary endpoint is the proportion in which the denominator includes all subjects 
who take at least one dose of the product (user population) and the numerator includes 
all subjects who do not use more than one dose(s) of the study product within the same 
menstrual cycle after taking the initial dose of ella®. 
9.3.3.6 I:  Self-Selection/Actual Use:  Proportion of self-selection population taking one 
of the “ask a doctor or pharmacist before use” products who do not select, who 
select but do not use or who report contacting a healthcare provider or 
pharmacist. 
This secondary endpoint is the proportion defined by the denominator including all 
subjects who participate in the self-selection interview who report taking one of the “ask 
a doctor or pharmacists before use” compounds (including barbiturates, carbamazepine, 
felbamate, oxcarbazepine, phenytoin, topiramate, rifampin, griseofulvin, a prescription 
drug to treat HIV/AIDS, bosentan, or a supplement containing St. John’s Wort) and the 
numerator is all such subjects who either do not select or use or who report talking with 
a doctor or pharmacist about it use during the course of the study.  
 Other Measures Analysis 
The other measures are all simple proportions where the user population represents the 
denominator. 
J. Proportion of user population who use a HBC method sometime during the past 
two menstrual cycles. 
K. Proportion of user population who used any EC on more than one occasion 
within the study period. 


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L. Proportion of user population who report becoming pregnant within the study 
period. 
9.4 
Safety Analysis 
Adverse event (AE) analyses will include all events which initially occurred, or worsened 
following treatment. Adverse events will be summarized by the Medical Dictionary for 
Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT) 
and classified according to their severity (mild, moderate, or severe) and relationship 
(related or not related) to study product. For the summary by severity, subjects who have 
multiple occurrences of the same AE will be classified according to the worst reported 
severity of the AE. Similarly, for the summary by relationship to the study product, the 
AE will be classified according to the worst relationship. 
9.5 
Interim Analysis 
There will be no interim analysis for this study 
9.6 
Missing Data 
All missing data will be considered missing and no statistical procedures will be 
employed to estimate or impute missing data. 
9.7 
Open-ended Data 
Verbatim responses will be coded as described in Section 8.4.4 above, with coded 
responses presented within individual question tables. For all verbatim responses 
(including those which were coded), listings will be generated and presented. 
10 DATA HANDLING AND RECORD KEEPING 
10.1 Data Collection Instruments / Electronic Data Record 
As used in this protocol, the term CRF should be understood to refer to a paper data 
record, an electronic data record or both, depending on the data collection method used 
in this study. 
A CRF is required and should be completed for each included subject. The completed 
original CRFs are the sole property of the Sponsor and should not be made available in 
any form to third parties, except for authorized representatives of the Sponsor or 
appropriate regulatory authorities, without written permission from the Sponsor. 
Each investigator has ultimate responsibility for the collection and reporting of all the 
clinical, safety, and laboratory data entered on the CRFs and any other data collection 
forms (source documents) that pertain to his or her phase of the study (enrollment 
interview and purchase for site investigators, follow up interviews and AE reports for the 
central investigator). Each investigator is responsible for ensuring that data collected are 
accurate, authentic/original, attributable, complete, consistent, legible, timely 
(contemporaneous), enduring, and available when required. The CRFs must be signed 
by the investigator or by an authorized staff member to attest that the data contained on 
the CRFs are true. Any corrections to entries made in the CRFs or source documents 


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must be dated, initialed, and explained (if necessary) and should not obscure the original 
entry.  
In most cases, the CRF, or part of the CRF, will also serve as source documents. In 
these cases, a document should be available at the investigator’s site as well as at the 
Sponsor and clearly identify those data that will be recorded in the CRF, and for which 
the CRF will stand as the source document. 
Data for this study will be entered directly into a validated EDC system. This system will 
provide a complete audit trail, which includes information about the initial data entry and 
all changes and deletions. When the data collection form is saved, data edits will check 
entries in each field and provide immediate notification to the interviewer of data that is 
unacceptable (a different value must be entered) or questionable (the data field must be 
checked and if left intact, an explanation must be given). Using this system, the 
interviewer will be able to correct entries or make clarifications while the subject is still 
being interviewed. 
All users will have a unique login user name and password, and system access 
privileges will be strictly controlled and documented. The audit trail, user access privilege 
processes, and electronic signatures collected by the system will be compliant with 21 
CFR Part 11 requirements. 
If the internet connection fails during the course of an interview, data collection will be 
completed on a paper copy of the electronic forms. When the internet connection is 
restored, study staff at the site will enter the data from the paper forms into the EDC 
system. If this were to occur, the completed paper copy of the electronic forms is the 
source document. Otherwise, the electronic record is the source. 
10.2 Study Documentation 
PEGUS Research will maintain accurate and complete records of the study. Study files 
and critical documents will be maintained at PEGUS Research throughout the study 
period, and will be retained or transferred to the Sponsor at its direction. 
10.3 Confidentiality of Study Documents and Electronic Records 
PEGUS Research holds all study-related documents and communications in the strictest 
confidence. PEGUS Research will ensure that the subject’s anonymity is maintained. On 
documents submitted to the Sponsor, subjects will not be identified by name or other 
personally identifiable information, but by numerical identification code. 
11 QUALITY CONTROL AND QUALITY ASSURANCE 
The procedures described herein pertaining to the conduct, evaluation and 
documentation of this study are designed to ensure that the Sponsor and study 
personnel abide by Good Clinical Practice (GCP) guidelines. The study will also be 
carried out in keeping with applicable local law(s) and regulation(s).  
SOPs from PEGUS Research will be followed to ensure quality. PEGUS staff will train 
and approve prospective interviewers prior to their work on the study. PEGUS Research 


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is responsible for selecting sites and training study personnel. Training will consist of an 
overview of the purposes and design of the study as well as detailed instructions on the 
methods, including subject recruitment, proper administration of the questionnaire, use 
of the EDC application and guidelines for correctly capturing and entering responses. A 
study-specific interviewer-training guide will be developed to serve as the basis for 
training. All training will be documented. 
Regulatory authorities, the Institutional Review Board / Independent Ethics Committee, 
and / or the sponsor’s or CRO’s clinical quality assurance group may request access to 
all source documents, CRFs, and other study documentation for on-site audit or 
inspection. Direct access to these documents must be guaranteed by the investigator, 
who must provide support at all times for these activities. 
12 ETHICS 
The study will be carried out in keeping with applicable local law(s) and regulation(s).  
12.1 Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
It is the responsibility of the investigator to have prospective approval of the study 
protocol, protocol amendments, informed consent documents, and other relevant 
documents, e.g., recruitment posters, if applicable, from the IRB/IEC. All 
correspondence with the IRB/IEC will be retained in the investigator file. Copies of 
IRB/IEC approvals will be forwarded to the Sponsor. 
The only circumstance in which an amendment may be initiated prior to IRB/IEC 
approval is where the change is necessary to eliminate apparent immediate hazards to 
the subjects. In that event, the investigator must notify the IRB/IEC and the Sponsor in 
writing immediately after the implementation. 
12.2 Ethical Conduct of the Study 
The study will be conducted in accordance with legal and regulatory requirements, as 
well as the general principles set forth in the International Ethical Guidelines for 
Biomedical Research Involving Human Subjects (Council for International Organizations 
of Medical Sciences 2002), Guidelines for GCP (ICH 1996), and the Declaration of 
Helsinki (World Medical Association 2013).  
In addition, the study will be conducted in accordance with the protocol, the International 
Conference on Harmonization (ICH) guideline on GCP, and applicable local regulatory 
requirements and laws. 
PEGUS Research will oversee the process for the approval of all Investigators, trial 
protocol, informed consent forms and other relevant trial documents. All correspondence 
with the IRB will be retained in the trial files for each site. All records identifying subjects 
will be kept confidential and, to the extent permitted by the applicable laws and/or 
regulations, will not be made publicly available. Subject names will be collected for 
compensation and follow-up purposes only and will not be linked to any study data. This 
information will not be supplied to the Sponsor or any other entity. No personally 


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identifiable information (PII) will be captured in the study database. In accordance with 
the Federal Privacy Standard, a Notice of Information Practices, which describes how 
subjects’ health information will be used and disclosed and how they can obtain access 
to this information, will be made available, if applicable. 
12.3 Subject Information and Consent 
All parties will ensure protection of subject personal data and will not include subject 
names or other identifiable data in any reports, publications, or other disclosures, except 
where required by law.  Explicit permission to gather sensitive data will be sought and 
documented prior to any data collection.  No PHI will be collected for subjects that 
screen fail, do not qualify for the use phase of the study, or choose not to sign consent.  
Any data collected after explicit permission is granted will be retained as anonymous 
study data for use by the sponsor. 
The informed consent documents must be in compliance with ICH GCP, local regulatory 
requirements, and legal requirements, including applicable privacy laws. 
The informed consent documents used during the informed consent process must be 
reviewed by the Sponsor, approved by the IRB/IEC before use, and available for 
inspection.  
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each subject before dispensing of study medication. The investigator will 
retain the original of each subject's signed consent document. 
Adolescents recruited in this study, as some may not have a high degree of parental 
involvement and since requirement of parental consent might introduce risk in some 
circumstances, are NOT children for the purposes of this study. This is allowed for in 45 
CFR 46.408 (c) “…if the IRB determines that a research protocol is designed for 
conditions or for a subject population for which parental or guardian permission is not a 
reasonable requirement to protect the subjects (for example, neglected or abused 
children), it may waive the consent requirements… provided an appropriate mechanism 
for protecting the children who will participate as subjects in the research is substituted, 
and provided further that the waiver is not inconsistent with federal, state, or local law. 
The choice of an appropriate mechanism would depend upon the nature and purpose of 
the activities described in the protocol, the risk and anticipated benefit to the research 
subjects, and their age, maturity, status, and condition.”  Since adolescents are 
presenting to the research sites seeking emergency contraceptives on their own accord, 
they meet the criteria for a mature minor in most states. Moreover, in most cases, 
adolescents seeking emergency contraception would not need parental consent for 
treatment and reproductive services in most states, and may not meet the definition of 
“children” in § 50.3(o) and thus would not be subject to the requirements of 21 CFR 50 
subpart D. The definition provided is “Children means persons who have not attained the 
legal age for consent to treatments or procedures involved in clinical investigations, 
under the applicable law of the jurisdiction in which the clinical investigation will be 
conducted.” However, depending on the age of the adolescent enrolling in the study, 
some state laws and regulations may preclude the adolescent from receiving 
contraceptive services without parent consent (i.e., under age 12 in many states). Where 


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state and local laws require, parental consent and adolescent subject assent will be 
documented. 
All records identifying subjects will be kept confidential, and to the extent permitted by 
the applicable laws and/or regulations, will not be made publicly available. Subject 
names will be collected for compensation and follow-up phone calls only. No personal 
identifiable information (PII) will be stored in the study database. This information will not 
be supplied to the Sponsor or any other entity. In accordance with the Federal Privacy 
Standard, a Notice of Information Practices, which describes how subjects’ health 
information will be used and disclosed and how they can obtain access to this 
information, will be made available, if applicable. 
Subjects’ implicit consent will be obtained prior to collecting any personally-identifiable 
contact information. Explicit verbal consent to gather sensitive data will be requested 
and documented prior to collecting any health or other sensitive information. 
Subject names, contact information, and other identifiable data will be maintained 
entirely separate from the study database. All parties will ensure protection of subject 
personal data and will not include subject names on any data forms, reports, 
publications, or in any other disclosures, except where required by laws. Personally-
identifiable data will be replaced by a numerical code consisting of a numbering system 
generated by the EDC system in order to de-identify the study subject. In case of data 
transfer, PEGUS will maintain high standards of confidentiality and protection of subject 
personal data. 
12.4 Liability and Insurance 
The Sponsor has subscribed to an insurance policy covering, in its terms and provisions, 
its legal liability for injuries caused to participating persons and arising out of this 
research performed strictly in accordance with the scientific protocol as well as with 
applicable law and professional standards. 
12.5 Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP 
In the event of any prohibition or restriction imposed (i.e., clinical hold) by an applicable 
competent authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the IP, the 
Sponsor should be informed immediately.  
In addition, the investigator will inform the Sponsor immediately of any urgent safety 
measures taken by the investigator to protect the study subjects against any immediate 
hazard, and of any serious breaches of this protocol or of ICH GCP that the investigator 
becomes aware of. 
12.6 Mandatory Reporting 
There will not be questions in the interview addressing personal sexual experience and it 
is not expected that subjects will spontaneously disclose information that would trigger 
mandatory reporting requirements. However, interviewers will be trained in the 
mandatory reporting conditions in each state where the interviews are conducted and to 


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identify such conditions if they are reported by subjects. Subjects will be informed in the 
introduction to the study that confidentiality will be strictly guarded, except for 
circumstances requiring reporting to authorities. 
13 SPONSOR DISCONTINUATION CRITERIA 
Premature termination of this study may occur because of a regulatory authority 
decision, change in opinion of the IRB/IEC, drug safety problems, or at the discretion of 
the Sponsor. In addition, the Sponsor retains the right to discontinue development of 
ella® at any time. 
If a study is prematurely terminated or discontinued, the Sponsor will promptly notify the 
investigator. After notification, the investigator must contact all participating subjects and 
the participating pharmacy and health center study sites. As directed by the Sponsor, all 
study materials must be collected and all CRFs completed to the greatest extent 
possible. 
14 PUBLICATION OF STUDY RESULTS 
14.1 Communication of Results by the Sponsor 
The Sponsor fulfills its commitment to publicly disclose clinical trial results through 
posting the results of studies on www.clinicaltrials.gov (ClinicalTrials.gov) and/or the 
European Clinical Trials Database (EudraCT), and other public registries in accordance 
with applicable local laws/regulations. 
15 EMERGENCY CONTACTS 
In emergency situations, the investigator should contact PEGUS Research Inc. by 
telephone on the number listed on the title page of the protocol. 
16 STUDY DURATION AND DATES 
The duration of this study is expected to be around 6 months (from first subject enrolled 
in the study until last subject last visit), with subject recruitment proposed to start mid Q2 
2017 and end in Q4 2017. The actual overall study duration or subject recruitment period 
may vary. 
 


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17 REFERENCES 
1. Murphy, Peggy W.; Davis, Terry C.; Long, Sandra W.; Jackson, Robert H.; Decker, 
Barbara C. Rapid Estimate of Adult Literacy in Medicine (REALM): a quick reading test 
for patients. Journal of Reading 1993 Oct; 37(2):124-30. 
2. Davis TC, Wolf MS, Arnold CL, Byrd RS, Long SW, Springer T, Kennen E, Bocchini 
JA. Development and validation of the Rapid Estimate of Adolescent Literacy in 
Medicine (REALM-Teen): a tool to screen adolescents for below-grade reading in health 
care settings. Pediatrics. 2006 Dec 1;118(6):e1707-14. 
3. Brache et al. A prospective randomised pharmacodynamic study of quick-starting a 
desogestrel progestin-only pill following ulipristal acetate for emergency contraception. 
Human Reproduction 2015; 30 (12) 2785-93. 
4. Zapata LB, Steenland M, Brahami D, Marchbanks PA, Curtis K. Effect of missed 
hormonal contraceptives on contraceptive effectiveness: a systematic review. 
Contraception 2013;87 (5): 685-700. 
 
 


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18 APPENDICES 
18.1 Mock Package and Drug Facts Label 
 
 
 
 


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18.2 Consumer Information Leaflet 
 
 
 
 
 


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STATISTICAL ANALYSIS PLAN 
 
A Multi-Center, Open-Label Trial Investigating  
Behavior Related to ella® Use in a Simulated OTC Environment 
(LIBRella) 
 
151032-001 
 
Final Version 2.0 
Date: 16 November 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PEGUS Research, Inc. 
 
 
CONFIDENTIAL


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Signatures 
 
Authors: 
 
Irene Brown     
 
 
_______________________    ____________________ 
Senior Statistician 
 
 
Signature 
 
                Date  
PEGUS Research, Inc. 
 
  
 
 
 
 
Approvals: 
 
Sarah Farnsworth 
 
    
_______________________    ____________________ 
VP, Scientific Affairs  
 
Signature 
 
                Date  
PEGUS Research, Inc. 
 
  
 
 
 
Russell Bradford 
 
    
_______________________    ____________________ 
Vice President, Medical Affairs 
Signature 
 
                Date  
PEGUS Research, Inc. 
 
  
 
 
 
Christine Adelbrecht  
 
_______________________    ___________________ 
Medical Affairs Manager,  
 
Signature 
 
               Date 
US Switches 
 
 
Laboratoire HRA Pharma 
 
 
 
Irene Laurora  
 
 
_______________________    ___________________ 
Vice President, US Medical Affairs 
Signature 
 
               Date 
Laboratoire HRA Pharma 
 
 


Irene Brown
Digitally signed by Irene Brown 
DN: cn=Irene Brown, o, ou, email=browni@pegus.com, 
c=US 
Reason: I am approving this document 
Date: 2018.11.05 12:44:22 -07'00'
Digitally signed by Russell D. Bradford, MD, MSPH 
DN: cn=Russell D. Bradford, MD, MSPH, o=PEGUS Research, 
Inc., ou=Vice President, Medical Affairs, 
email=bradfordr@pegus.com, c=US 
Reason: I am approving this document 
Date: 2018.11.05 15:41:59 -07'00'




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TABLE OF CONTENTS 
1 
INTRODUCTION .............................................................................................................................................. 5 
2 
TRIAL OBJECTIVES ....................................................................................................................................... 7 
3 
TRIAL DESIGN ................................................................................................................................................. 8 
3.1 
Eligibility Criteria ............................................................................................................. 9 
3.2 
Sample Size ................................................................................................................. 10 
3.3 
Randomization .............................................................................................................. 11 
4 
GENERAL STATISTICAL CONSIDERATIONS ........................................................................................ 11 
4.1 
General Principles ........................................................................................................ 11 
4.2 
Handling of Dropouts .................................................................................................... 11 
4.3 
Handling of Missing Data .............................................................................................. 11 
4.4 
Protocol Violations ........................................................................................................ 11 
4.5 
Interim Analyses and Data Monitoring .......................................................................... 12 
4.6 
Electronic Data Capture and Data Entry Rules ............................................................ 12 
4.7 
Data Review ................................................................................................................. 13 
5 
ANALYSIS SETS ............................................................................................................................................. 13 
6 
STATISTICAL METHODOLOGY ................................................................................................................ 13 
6.1 
Population Characteristics ............................................................................................ 14 
6.2 
Efficacy ......................................................................................................................... 14 
6.3 
Pharmacokinetics / Pharmacodynamics ....................................................................... 14 
6.4 
Evaluation of Use ......................................................................................................... 14 
6.4.1 
Primary Analysis .................................................................................................... 14 
6.4.2 
Secondary Analysis ............................................................................................... 16 
6.4.3 
Other Analyses ...................................................................................................... 22 
6.4.4 
Adverse Events ..................................................................................................... 23 
7 
CHANGES TO PLANNED ANALYSIS......................................................................................................... 23 
8 
DATASETS AND SUPPORTING DOCUMENTATION ............................................................................. 24 
8.1 
Datasets ....................................................................................................................... 24 
8.2 
Supporting Documentation ........................................................................................... 24 
9 
DOCUMENT HISTORY AND CHANGES IN THE PLANNED STATISTICAL ANALYSIS ............... 24 
10 
REFERENCES ................................................................................................................................................. 25 
11 
APPENDICES ................................................................................................................................................... 26 
11.1 
Final Data Collection Instrument (DCI) ......................................................................... 26 
 
LIST OF TABLES AND FIGURES 
Table 1 Two-sided 95% CIs for Various Sample Sizes Around 85% Point Estimate.................. 10 
Table 2 Self-Selection Decision Outcomes ................................................................................. 17 
 
Figure 1. Flow Chart of Study Procedures .................................................................................... 6 
 
 
 


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Glossary and Abbreviations 
 
aCRF 
Annotated Case Report Form 
ADaM 
Analysis Data Model 
AE 
Adverse Event 
AUT 
Actual Use Trial 
CDISC 
Open-Clinical Data Interchange Standards Consortium 
CSR 
Clinical Study Report 
CI 
Confidence Interval 
CIL 
Consumer Information Leaflet 
DCI 
Data Collection Instrument 
DFL 
Drug Facts Label 
DMP 
Data Management Plan 
EC 
Emergency Contraceptive 
EDC 
Electronic Data Capture 
EOS 
End-of-Study 
FDA 
Food and Drug Administration 
HBC 
Hormonal Birth Control 
ICF 
Informed Consent Form 
IP 
Investigational Product 
MedDRA 
Medical Dictionary for Regulatory Activities 
OTC 
Over-the-Counter 
PT 
Preferred Term 
REALM 
Rapid Estimate of Adult Literacy in Medicine 
REALM-Teen 
Rapid Estimate of Adolescent Literacy in Medicine 
Rx 
Prescription 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SDTM 
Study Data Tabulation Model 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UPA 
Ulipristal Acetate 
 
 
 


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1 
Introduction 
This Actual Use Trial (AUT) is designed to evaluate consumers’ use of ella® (ulipristal acetate 
[UPA]) under conditions that emulate actual over-the-counter (OTC) use. The study will assess 
whether consumers use the product in a manner consistent with the labeling and provide 
measures of how and when consumers select to use and use the product. AUT design is 
somewhat different than efficacy trials in that the study looks at subject compliance to directions 
and dosing information. Where applicable, descriptions have been included where language 
from efficacy trials may be used in slightly different ways for compliance measures. 
 
The purpose of this document is to provide a more technical and detailed elaboration of the 
principal features of the analysis described in the protocol, and to include detailed procedures 
for executing the statistical analysis of the primary and secondary endpoints and other data. 
 
This Statistical Analysis Plan (SAP) assumes familiarity with the final Protocol v3.2 dated 15 
Dec 2017 titled “A Multi-Center, Open-Label Trial Investigating Behavior Related to ella® Use in 
a Simulated OTC Environment (LIBRella). In particular, the SAP is based on the planned 
analysis specification as written in LIBRella Protocol Section 9 “Data Analysis/Statistical 
Methods”. Therefore, SAP readers may consult the LIBRella Protocol for more background 
information on the study, e.g., on study objectives, study design and population, treatments, 
definition of measurements and variables, and planning of sample size. However, it is important 
to note that the updated study design elements related to the addition of adolescent-only clinic 
sites described in Protocol v3.2 were never implemented prior to this trial being placed on a 
Partial Clinical Hold by the Food and Drug Administration (FDA) on 18 January 2017. Therefore, 
these changes to the study are not reflected within the SAP (i.e., change to exclusion criteria 
and removal of requirement to purchase the product at the adolescent-only sites).  
 
The following flow chart in Figure 1 below is included to provide an overview of data collection 
and analysis populations, see Section 5 for additional description of the analysis populations. 
 


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Figure 1. Flow Chart of Study Procedures 


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2 
Trial Objectives 
The overall purpose of this study is to evaluate the adequacy of the proposed OTC labeling to 
guide appropriate consumer behavior in an OTC-like setting when selecting and using ella®. 
The behavior will be measured by pre-specified endpoints. The determination of the endpoints 
and other measures is based on the potential clinical consequences of a consumer failing to 
heed each key label instruction and concerns raised with regard to the potential misuse of the 
product in an OTC setting. Endpoints are designated either as Actual Use endpoints or Self-
Selection endpoints. Note that the “Other Measures” listed below are not endpoints but rather 
will be used to help characterize the study population in the analysis. 
 
Actual use endpoints measure compliance with label directions for correct use of the 
investigational product (IP). Self-selection endpoints measure the ability of subjects who review 
the label information and make a decision about whether the investigational product is 
appropriate for their use. This is a complex behavior that requires the subject to synthesize 
information and directions on the label with the knowledge of their current health status and any 
previous experience with the product class. There are populations of interest that are excluded 
from the use phase of this study (women who are pregnant or breastfeeding, males). To 
address Food and Drug Administration (FDA) requests for information on the ability of these 
potential consumers to correctly identify that it would not be appropriate for them to use the 
product, they are instructed to review the label information, make a selection and purchase 
decision and demographics are collected. These subject data are used for analysis of the self-
selection endpoints but not to have use data to be included in the actual use endpoints. See 
Section 5: Analysis sets for further description on the study populations. For detail on the 
classification of subjects as appropriate for use and correct/acceptable/incorrect self-selection, 
see Section 6.4.2.1. 
 
Primary Endpoints  
A. Actual Use: Proportion of dosing instances (each recorded use/dose of the study medication) 
among user population taken within 120 hours (5 days) of most recent episode of unprotected 
sex. (Compliance with timing) 
 
B. Actual Use: Proportion of dosing instances among user population in which no more than one 
tablet was taken. (Compliance with dose) 
 
C. Self-Selection: Proportion of female selectors (those who selected to use the product during 
the self-selection interview) who are not pregnant at the time of selection decision. (Indirect 
measure of intended compliance with absence of pregnancy) 
 
Secondary Endpoints 
D. Self-Selection: Proportion of females in the self-selection population (any female who 
completed the self-selection interview) who make a correct selection decision with regards to 
breastfeeding at the time of selection decision. (Indirect measure of intended compliance with 
absence of breastfeeding) 
 
E. Self-Selection: Proportion of self-selection population who make a correct selection decision 
regarding use of the product. (Compliance with Do Not Use and Ask a Doctor Before Use Drug 
Facts Label directions) 
 


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F. Actual Use: Proportion of dosing instances among user population in which hormonal birth 
control (HBC) is not taken for 5 days after taking ella®. (Compliance with post-dose instruction) 
 
G. Actual Use: Proportion of dosing instances among user population associated with use of 
hormonal contraceptives in the same cycle after taking ella® in which subject reports using a 
condom (or other barrier method) every time they have sex until their next menstrual period. 
(Compliance with post-dose instruction) 
 
H. Actual Use: Proportion of user population who do not use the study product more than once 
in the same menstrual cycle. (Compliance with post-dose instruction) 
 
I. Self-Selection/Actual Use: Proportion of self-selection population taking one of the “ask a 
doctor or pharmacist before use” products who do not select, who select but do not use or who 
report contacting a healthcare provider or pharmacist. (Compliance with possible Drug-drug 
Interaction directions) 
 
Other Measures 
J. Actual Use: Proportion of user population who used a HBC method sometime during the past 
two months. 
 
K. Actual Use: Proportion of user population who used any emergency contraceptive (EC) on 
more than one occasion within the study period. 
 
L. Actual Use: Proportion of user population who report becoming pregnant within the study 
period. 
3 
Trial Design 
This is an observational open-label, multicenter, 6-week study designed to create as much as 
possible an OTC-like environment in which subjects will make a self-selection and purchase 
decision about ella® based only on their reading of the outside of the package including the 
Drug Facts Label (DFL). This is not a randomized trial and there is only one study product that 
subjects will use based on their own understanding of the directions included on the DFL and 
Consumer Information Leaflet (CIL); there is no protocol--directed dosing schedule. Qualified 
subjects who choose to purchase the study medication will do so, then leave the study site and 
use the product on their own. The study is designed to assess if, when and how subjects use 
the medication in an OTC-like environment. 
 
This trial is a multi-center trial conducted in a naturalistic environment. Study characteristics and 
procedures were designed to make it as naturalistic as possible. Some of the key naturalistic 
elements include the following: 
 
• 
There are minimal study exclusionary criteria imposed on subjects, making this trial 
nearly an all-comers study to mimic the likely OTC population. 
• 
The study will be conducted in women’s health clinics and pharmacies, representing 
typical locations where consumers now commonly purchase EC in an OTC-like setting. 
• 
The proposed OTC packaging and labeling is the only product information provided to 
subjects during the study. Subjects will only review the outer packaging at the initial visit. 
Study staff will not provide any additional information or encouragement regarding 


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product selection at that visit. Staff will not answer subject questions but will redirect 
them to the outer package. 
• 
After purchasing the study product, subjects will take the package with them when they 
leave the site; the package will include the outer packaging and, inside the package, the 
consumer information leaflet (CIL) and study medication. 
• 
Subject characteristics and how they might be related to behaviors directed by the DFL 
that are gathered at screening, enrollment, or during the 6-week study period will not be 
discussed directly with subjects until the end of study (EOS) interview.  
 
3.1 
Eligibility Criteria 
For the self-selection phase, subjects must meet the following screening inclusion criteria to 
begin the enrollment interview: 
 
1) Able to read, speak and understand English  
2) Can see well enough to read information on the label  
3) Another member of the respondent’s family has not participated in this study  
4) Consumer or someone else in the household does not work for a market research or 
advertising company, public relations firm, news organization, pharmacy or 
pharmaceutical company, medicine manufacturer, as a healthcare professional, or as 
part of a health care practice, managed care or health insurance company, trained or 
worked as a healthcare professional or market research professional (eliminated for 
reasons of confidentiality and increased awareness of medicines and their labels)  
5) Has not participated in a health-related market research or product label study in the 
past 12 months  
6) Has not participated in a clinical trial in the past 12 months 
7) Has never participated in a study about EC  
8) Seeking the use of emergency contraception 
 
Additionally, subjects must meet all of the following inclusion criteria to be eligible for enrollment 
into the use phase of the study:  
 
1) Evidence of a personally signed and dated informed consent form (ICF) indicating that 
the subject (or a legal representative) has been informed of all pertinent aspects of the 
study.  
2) Willing and able to comply with the initial visit and planned phone calls and other study 
procedures.  
 
All subjects will then be asked to make a selection decision. Those presenting with any of the 
following will not be included, so the exclusion criteria for Use Phase: 
 
1) Unwilling to purchase study medication. 
2) Unwilling to provide written informed consent. 
3) Unwilling or unable to provide contact information.  
4) Unwilling to state that the product is for their own use and no one else’s.  
5) Pregnant, by self-report or by a urine pregnancy test.  
6) Male.  


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7) Known allergy to ulipristal acetate or inactive ingredients.  
8) Currently breastfeeding.  
9) Premenarchal (have not experienced a first menstrual cycle). 
  
Subject eligibility will be reviewed and documented by the Investigator or his/her designee 
before subjects are allowed to purchase and/or begin the use phase of the study. 
 
3.2 
Sample Size 
The planned sample size for this study is approximately 950 use phase participants. Given that 
subjects are recruited after independently seeking EC, most of those who enter the self-
selection phase are expected to purchase, and most use phase participants are expected to 
actually use the study product (UPA 30mg) during the study. If approximately 75% of subjects 
pass the screening criteria, self-select and both qualify and agree to purchase and enter the use 
phase, it is expected that up to 1270 subjects will need to be interviewed to yield 950 
purchasers.  
 
Assuming approximately 950 use phase participants, if 80% of those use the product within the 
study period, that would yield a user population of 760. Estimating approximately 40% of users 
will have had recent hormonal contraceptive use would yield a recent hormonal contraceptive 
user population of 305. Allowing for a further 20% loss to follow-up yields a user population of 
approximately 608 and a recent hormonal contraceptive user population of 245.  
 
Given that adolescents are a subgroup of interest in the study, adult subjects will be constrained 
to no more than 775 subjects, allowing for an adolescent subgroup number of approximately 
175. Further, the group of older adolescents (age 15 and older) will be constrained to 125, to 
allow for approximately 50 subjects under the age of 15. If 15% of 950 subjects are classified as 
low literacy by the Rapid Estimate of Adult Literacy in Medicine (REALM)1 (for adults) or Rapid 
Estimate of Adolescent Literacy in Medicine (REALM-Teen)2 (for adolescents under age 18), the 
cohort of low literacy subjects will be approximately 143 subjects, representing a low literary 
subgroup of sufficient size.  
 
Because actual use trials are not hypothesis-testing comparative trials, study sample size is 
designed to allow for adequate evaluation of key endpoints across all subjects and among 
several subgroups. As the analysis of actual use trials typically focuses on estimating the 
proportion (and associated 95% confidence intervals) of individual endpoints, sample size is 
most often based on the number of subjects needed to constrain the confidence interval (CI) to 
a limited range. For this study, assuming 85% correct compliance behavior (the confidence 
interval depends on the actual point estimate), a sample of 608 subjects would constrain the CI 
to ±3.1%. For purposes of illustration, Table 1 provides the 2-sided exact 95% confidence 
interval for various sample sizes around a point estimate of 85%. 
 
Table 1 Two-sided 95% CIs for Various Sample Sizes Around 85% Point Estimate 
 
N=760a 
N=608b 
N=245c 
N=143d 
95% CI around a point estimate of 85% 
±2.7% 
±3.1% 
±5.1% 
±7.0% 
 
a  Approximate user population (maximum) 
b  Approximate user population (allowing for loss-to-follow up) 


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c  Approximate recent hormonal contraceptive users 
d  Approximate low-literacy subjects (8th grade-level as measured by the REALM or REALM-Teen 
Test) 
 
3.3 
Randomization 
There is no randomization in this study. 
4 
General Statistical Considerations 
4.1 
General Principles 
Statistical analyses of the data will be performed by PEGUS Research using the SAS System 
for Windows v 9.4 (SAS Institute, Cary, NC). All analyses performed in this study will be 
descriptive. 
 
4.2 
Handling of Dropouts 
For subjects that choose to withdraw at any point during the study, an attempt to collect End-of-
study (EOS) information and the reasons for the subject’s early termination will be conducted. 
Data gathered prior to subject withdrawal and any ongoing data collection will be included in the 
analysis for completed questions, unless the subject withdraws consent or requests otherwise. 
Subjects who do not complete the study will be described in a disposition table, which will 
provide complete traceability of all subjects who began the screening process and detail of 
those subjects who qualified, the number that went on to select, purchase, and use the IP. Any 
subjects who withdrew their consent or were determined to be lost to follow-up will be described 
in the disposition table as well. Drop-outs will not be replaced. 
 
4.3 
Handling of Missing Data 
Missing data will not be imputed; the statistical analyses will be based on cases with relevant 
data available. For endpoint calculations, if missing data makes it so a case (subject or a dosing 
instance) cannot be classified as to whether or not it belongs in the numerator, that case will 
also be excluded from the denominator. All missing data will be flagged, and a reason for why 
the data are missing will be described in a footnote in each applicable statistical table.  
 
4.4 
Protocol Violations 
Potential subjects will be screened for inclusion and exclusion criteria for the different interview 
phases described in Section 3.1. Subjects who enter the use phase in violation of the 
inclusion/exclusion criteria is a protocol violation. In these cases, subjects will be included in the 
relevant analysis population unless the inclusion/exclusion criteria that were violated would bias 
the analysis of a study endpoint. However, these subjects would be included in safety analyses 
if they had taken the study drug.  
 
All violations to the study procedures are tracked/managed by the project manager. Of note, 
because use of the product is not driven by protocol, non-compliance with the label is not a 
protocol violation and are captured in relevant study endpoints. All protocol violations will be 
reviewed by the study team before database lock to evaluate violation magnitude as major or 
minor, based on the impact on analysis of the endpoints, and therefore the subject’s eligibility 
for any analysis population. Subjects with protocol violations will be summarized by the violation 
severity and category. In the instance of any duplicate subjects enrolling in the trial, both 


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records will be retained in the database for the duplicate subject, but only the first instance will 
be used in the analysis.  
 
4.5 
Interim Analyses and Data Monitoring 
No designed interim analyses will be conducted. Reviews on progress of enrollment and 
characteristics of enrollees and other data points important to this study will be looked at 
periodically from the source data being collected. 
 
Note that a targeted analysis and reporting activity was completed at the request of the FDA 
while study data were still being collected from subjects and data review and cleaning were 
ongoing. FDA notified HRA on 18 Jan 2018 that the LIBRella study (and any others 
investigating UPA) was placed on a Partial Clinical Hold, and requested that no additional 
subjects enroll into the study, for all subjects to return any unused IP, and that additional data 
be gathered to determine if there was any detectable safety signal related to liver function in the 
user population. Subjects who were still enrolled in the study were asked additional targeted 
health questions in a telephone interview conducted by PEGUS Research nurses, and were 
then directed to return to the study site for a liver function blood test.  These additional study 
procedures were described in an Administrative Letter to the study protocol. The data were 
summarized and provided to FDA in March 2018. No safety signal was detected. The Liver 
Safety Report will be included as an Appendix to the Clinical Study Report (CSR), but will not be 
described within the body of the CSR. In addition, all liver safety data will be included in the raw, 
source datasets. No interim analysis of protocol-defined study endpoints was conducted during 
the liver safety analysis.  
 
4.6 
Electronic Data Capture and Data Entry Rules 
Information collected during the subject interviews will be entered directly into an Electronic 
Data Capture (EDC) application (DATATRAK ONE, DATATRAK International, Inc.). Automatic 
data checks will alert users of discrepancies and inconsistencies, where applicable. In the event 
of a data entry error, trained study staff interviewers conducting enrollment and follow-up 
interviews will have the ability to correct information previously entered. Data Management will 
review the information entered as defined in the study protocol and Data Management Plan 
(DMP). 
 
All system users will have a unique login user name and password, and system access 
privileges will be strictly controlled and documented. Whenever data is modified after the initial 
data entry process, a computer-generated audit trail entry will be created. The audit trail, user 
access privilege processes, and electronic signatures collected by the system will be compliant 
with 21 CFR Part 11 requirements. 
 
If an internet connection is not available, the interview will not be started. If the internet 
connection is lost during the course of an interview, a paper copy of the electronic forms will be 
available to complete the interview. When the Internet connection is restored, study staff at the 
site will enter the data from the paper forms into the EDC system. If this were to occur, the 
completed paper copy of the electronic forms is the source document. Otherwise, the electronic 
record is the source.  
 
A detailed DMP describes procedures to ensure the proper management and quality of study 
data and additional PEGUS Standard Operating Procedures (SOPs) specify the activities 
performed to ensure the quality, accuracy and reliability of the statistical analysis and the final 
study report. 


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4.7 
Data Review 
Data review will be ongoing during the course of this study. Data will be reviewed by PEGUS 
Research for accuracy and all validation and documentation will be done before database lock. 
Study Data Tabulation Model (SDTM) datasets will also be created from the source data and 
Analysis Data Model (ADaM) datasets for analysis will be created from the SDTM datasets. 
Review cycles will be established to maintain integrity with standard SDTM and ADaM domains. 
Open-Clinical Data Interchange Standards Consortium (CDISC) validator software will be used 
to flag for errors and inconsistencies to help in creating FDA compliant datasets. 
5 
Analysis Sets 
The statistical analysis will be based on the following populations of interests. The operational 
definition for each population is included, and is based on the final Data Collection Instrument 
(DCI; see Appendix 11.1): 
 
• 
Responder Population: Subjects who accept the invitation to participate and begin the 
screening process (including those who do not meet screening criteria for proceeding to 
the self-selection phase). 
o Section 3, Question 2 not blank 
• 
Self-Selection Population: Subjects who accept the invitation to participate and meet 
study inclusion screening criteria, participate in a face-to-face interview at the study site 
and make a self-selection decision (including purchase decision when relevant). Both 
the self-selection decision and the purchase decision are used to classify subjects as to 
whether they are a selector or a non-selector.  
o Subjects coded as selector or non-selector in manual coding process (described 
in study protocol)  
• 
Purchasers (Use Phase Participants): Subjects who meet study enrollment criteria and 
purchase/obtain the study medication. 
o Section 14, Question 41 answered “Yes” 
• 
User Population: Subjects who take at least one dose of study medication during the 
study. 
o Section 19, Question 1 answered “Yes” OR Section 21, Question 1 answered 
“Yes” 
• 
Recent hormonal contraceptive users: Subjects in the user population who also report 
recent hormonal contraceptive use (i.e., use of a hormonal contraceptive within the 
previous two months). 
o (Section 19, Question 1 answered “Yes” OR Section 21, Question 1 answered 
“Yes”) AND [(Section 7, Question 30 answered “Yes” AND Section 7, Question 
30a answered one or more of boxes 1-6) OR (Section 7, Question 32 answered 
“Yes” AND Section 7, Question 32a answered one or more of boxes 1-6 AND 
Section 7, Question 32b answered ≤60 Days ago OR ≤8 Weeks ago OR ≤2 
Months ago)]  
6 
Statistical Methodology 
Frequencies and percentages will be presented for categorical data, mean, standard deviation 
(SD); median, and range will be presented for numerical data. Percentages will be rounded to 
one decimal place. The category of missing data will be displayed only if there are actually 
missing values. Frequencies, percentages and 2-sided 95% CI will be calculated for the primary 


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and secondary endpoints using the exact method. For the primary endpoints, it will be 
concluded that the established target threshold is reached if the lower limit of the CI of the point 
estimate is equal to or exceeds the value of the pre-determined threshold (thresholds for 
primary endpoints are presented below in Section 6.4.1). 
 
Note that Statistical Table Shells are available for review as a separate study document.  
 
6.1 
Population Characteristics 
A summary of the disposition of subjects (including responders, self-selection population, 
purchasers and users) and reasons for exclusion from these populations will be provided. 
Demographic characteristics, medical history and other background information will be 
summarized for the responder, self-selection, purchaser, and user populations. 
 
Demographics and endpoint results will be presented for subgroups of interest, with subjects 
dichotomized on the corresponding variables, which include (but are not necessarily limited to) 
literacy, gender, age (adolescent vs. adult women, and women <20 years of age vs ≥20 years of 
age), and history of HBC use.  
 
In addition, all self-selection endpoint results for adolescents will be presented separately for 
adolescents recruited via clinician referral vs. adolescents recruited in other ways in order to 
estimate any impact of clinician referral on self-selection endpoints. 
 
6.2 
Efficacy 
Not applicable to this study. 
 
6.3 
Pharmacokinetics / Pharmacodynamics 
Not applicable to this study. 
 
6.4 
Evaluation of Use 
Several of the endpoints are based on dosing instance, rather than by subject, as subjects have 
the potential to take more than one dose over the course of the study. However, for each of 
those endpoints a secondary analysis by subject will also be presented as applicable. 
 
6.4.1 Primary Analysis 
Frequencies, percentages and two-sided exact 95% confidence intervals will be calculated for 
the endpoints for the applicable study populations (as defined in Section 5) and for selected 
subgroups (as described in Section 6.1). The target threshold for the three primary endpoints is 
90%. The objective will be considered met for these endpoints if the lower bound of the 2-sided 
95% CI for each endpoint evaluated for the entire study population meets or exceeds the 
established threshold.  
 
A. Actual Use: Proportion of dosing instances among user population taken within 120 
hours (5 days) of most recent episode of unprotected sex.  
 
The first primary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP and the numerator includes all dosing instances of the IP which were 
taken within 120 hours (5 days) of the subject’s most recent episode of unprotected sex. 
A time parameter will not be used in collecting the dates for the calculation of the 
numerator. Rather, as subjects are more likely to focus on the larger time blocks (days), 
the numerator will be calculated as all dosing instances where (date of ingestion of 


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tablet-date of most recent unprotected sex ≤ 5 days). It is possible that this type of date 
comparison may lead to the inclusion of a few subjects who took the IP within 5 calendar 
days, but more than 120 hours after unprotected sex (depending on time of day for the 
two dates). However, given that it will be within the labeled 5 calendar days, inclusion of 
these subjects in the numerator will be acceptable. Additionally, frequencies of number 
of days between unprotected sex and use of EC will be presented. 
 
Endpoint operationally defined as follows:  Total dosing instances (denominator) is the 
count of all discrete instances of Section 19, Question 3 plus all discrete instances of 
Section 21, Question 3.  Total dosing instances where the IP was taken within 120 hours 
(5 days) of the subject’s most recent episode of unprotected sex (numerator) is the count 
of all discrete instances where Section 19, Question 3b minus Section 19 Question 3 
≤120 hours OR ≤5 days plus all discrete instances where Section 21, Question 3b minus 
Section 21 Question 3 ≤120 hours OR ≤5 days. 
 
B. Actual Use: Proportion of dosing instances among user population in which no more 
than one tablet was taken.  
 
The second primary endpoint is the proportion in which the denominator is all discrete 
dosing instances of the IP and the numerator includes all dosing instances where no 
more than one tablet of UPA (IP or prescription (Rx)) was taken.  
 
Endpoint operationally defined as follows:  Total dosing instances (denominator) is the 
count of all discrete dosing instances of Section 19, Question 3 plus all discrete 
instances of Section 21, Question 3, plus all discrete instances of Section 19, Question 
5c, plus all discrete instances of Section 21, Question 5c.  Total dosing instances where 
no more than one tablet was taken (numerator) is the count of all discrete instances 
where Section 19, Question 3a =1, plus all discrete instances where Section 21, 
Question 3a =1, plus all discrete instances where Section 19, Question 5d = 1, plus all 
discrete instances where Section 21, Question 5d=1. 
 
Results for this endpoint will also be presented by subject, expressed by the proportion 
in which the denominator is all subjects in the user population, and the numerator 
includes all subjects who took no more than one tablet in all of their dosing instances. 
 
Endpoint operationally defined as follows:  User population (denominator) is the count of 
all subjects who answered “Yes” to Section 19, Question 1 OR answered “Yes” to 
Section 21, Question 1.  Total number of subjects who took no more than one tablet of 
UPA (numerator) is the count of all subjects for whom any responses provided to 
Section 19, Question 3a, Section 21, Question 3a, Section 19, Question 5d, and Section 
21, Question 5d all =1. 
 
C. Self-Selection: Proportion of female selectors (those who selected to use the product) 
who are not pregnant at the time of selection decision.  
 
The third primary endpoint is the proportion in which the denominator includes all 
females who selected to use the product (regardless of whether they purchased/used) 
and the numerator includes all female selectors who were not pregnant at the time of the 
selection decision. Pregnancy status will be based on results of the pregnancy test, if 
available. For subjects who did not proceed far enough in the interview to take the 


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pregnancy test, their self-reported pregnancy status will be used. In the case of subjects 
that report not being pregnant, sign consent and then receive a positive result on the 
pregnancy test, their selection decision made prior to the pregnancy test will be used for 
formal analysis of this endpoint, though this measure will also be presented taking into 
account their selection decision made after the pregnancy test for informational 
purposes only.  
 
Endpoint operationally defined as follows:  Selector population (denominator) is the 
count of all subjects who were coded as a selector in selector coding.  Selectors who 
were not pregnant at selection (numerator) includes all subjects who were coded as a 
selector in selector coding AND ((Section 12, Question 36b answered “Negative) OR 
(Section 12, Question 36b is null and Section 7, Question 27 is not answer “Yes”) OR 
(Section 12, Question 36b is “Positive” but subject indicates she had a very recent 
abortion)).  
 
6.4.2 Secondary Analysis 
D. Self-Selection: Proportion of females in the self-selection population who make a correct 
selection decision with regard to breastfeeding.  
 
The first secondary endpoint is the proportion in which the denominator includes all 
females in the self-selection population and the numerator includes those who made a 
correct decision with regard to breastfeeding, specifically, all women in the self-selection 
population minus any selectors who were breastfeeding at the time of the selection 
decision.  
 
Endpoint operationally defined as follows: Self-selection population (denominator) 
defined as Section 4, Question 13 not blank. Those who made a correct decision with 
regards to breastfeeding (numerator) includes the Self-selection population minus any 
subjects who were coded as a selector in selector coding.  AND who answered “Yes” to 
Section 7, Question 29. 
 
E. Self-Selection: Proportion of self-selection population who make a correct selection 
decision.  
 
This endpoint is the proportion of those subjects making the self-selection decision who 
make a correct decision about whether the product is right for them to use, as outlined 
below. Operational definitions of Correct, Acceptable and Incorrect Selectors are 
detailed in Section 6.4.2.1 below. 
 
 
6.4.2.1 Conceptual Approach to Self-Selection 
Conceptually, the selection decision can be characterized as a 2x2 table (Table 2 below) where 
the participant's decision to select or not select the study product for use is crossed with 
whether or not it is appropriate to use, based on participant's self-reported health status and 
clinical characteristics. 


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Table 2 Self-Selection Decision Outcomes 
Participant’s 
Selection Decision 
Appropriate to Use 
YES 
NO 
YES (selectors) Cell A 
Correct Decision 
Cell B 
Incorrect Decision 
NO (non-selectors) Cell C 
Incorrect Decision 
Cell D 
Correct Decision 
The four cells in the self-selection matrix can be characterized as follows.  
Cell A: Participants who say the study product is right for them to use and based on their 
self-reported medical and demographic information, the study product is right for them to 
use.  
Cell B: Participants who say the study product is right for them to use and based on their 
self-reported medical and demographic information, the study product is not right for 
them to use.  
Cell C: Participants who say the study product is not right for them to use and based on 
their self-reported medical and demographic information, the study product is right for 
them to use.  
Cell D: Participants who say the study product is not right for them to use and based on 
their self-reported medical and demographic information, the study product is not right 
for them to use. 
Each subject will be classified on two key variables: (1) the selection decision and (2) the 
appropriateness of use given the selection decision, in order to populate the typical 2x2 
self-selection table. 
 
Selection Decision: The selection phase of the interview consists of the self-selection 
and purchase questions, with accompanying neutral follow-up questions. All subjects 
who go on to actually purchase the study product will be categorized as selectors in 
selector coding. Even subjects who do not eventually complete the purchase of the 
product will be classified as a selector or a non-selector primarily on the basis of the 
initial self-selection and purchase questions. However, all information recorded during 
the selection phase of the interview will be considered in the classification of subjects as 
selectors or non-selectors. This is completed in a manual coding process, where 
subjects are coded as selectors and non-selectors.  
 
 
Appropriate to Use: 
Non-selectors will be classified on the variable Appropriate for Use as follows: 
 
Yes: meets the label criteria for use, representing those who could have selected 
appropriately, but did not (Cell C). 
 
No: does not meet the label requirements for use, and appropriately did not 
select (Cell D). This includes those subjects who otherwise might have met the 
strict criteria for appropriate use according to the DFL, but who give a medically 


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appropriate rationale for their non-selection decision. For example, if a subject 
who otherwise meets the labeled criteria for use does not select the product and 
cites the fact that they are taking a medicine for Human Immunodeficiency Virus 
(HIV) as their reason for not selecting (which otherwise does not disqualify a 
subject from using, but rather suggests that they talk to a doctor), that subject will 
be re-classified from Cell C to Cell D. A physician will review the casebook for 
each subject who falls into Cell C to determine if any subjects meet that criterion. 
 
Selectors will be classified on the variable Appropriate for Use as follows: 
 
Yes: either meets the strict label criteria for use (1-Correct Selectors) or reported 
and measured characteristics justify the selection decision (2-Acceptable 
Selectors), representing those who chose to use the product who made a 
clinically acceptable decision despite not meeting the strict label criteria for use 
(Cell A). 
 
No: does not meet strict label criteria and reported and measured characteristics 
do not justify the selection decision (3-Incorrect Selectors), representing those 
who chose to use the product, but should not have (Cell B). 
 
Complete definitions of Correct, Acceptable, and Incorrect Selectors follow: 
 
1) Correct Selectors. Subject meets the strict criteria of the Drug Facts label, including: 
 
a) No contraindications (not pregnant or breastfeeding, no known allergy to any of 
the ingredients, no previous use of ella® within the same menstrual cycle)  
 
Operationally defined as follows: 
• 
Not Pregnant:  Section 12, Question 36b is “Negative” OR (Section 12, 
Question 36b is null and Section 7, Question 27 not answered “Yes”) OR 
Section 12, Question 36b is “Positive” but subject indicates she had a 
very recent abortion 
• 
Not Breastfeeding:   Answered “No” to Section 7, Question 29. 
• 
No Allergy:  Answered “No” to all parts of Section 7, Question 25 and 25a. 
• 
No previous use of ella® within the same menstrual cycle:  Did not answer 
“No” to Section 19, Question 10d OR did answer “Advance provision” to 
Section 5, Question 15.  
 
b) Is a woman of childbearing potential. This would include all women who do not 
report any of the following: surgical sterilization (tubal ligation, hysterectomy, or 
bilateral oophorectomy), congenital malformation/defect, endometrial ablation, or 
postmenopausal for at least one year  
 
Operationally defined as follows:  Answered “Yes” to Section 7, Question 28 OR 
none of boxes 1-6 checked in Section 7, Question 28a. 
 
c) Has had unprotected sex in the 5 days prior to purchase of the product or is 
purchasing for future use 
 


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Operationally defined as follows:  Checked box 2 to Section 5, Question 15 OR 
answered ≤120 hours or ≤5 days to Section 5, Question 17. 
 
2) Acceptable Selectors. Subject does not meet the strict criteria of the Drug Facts 
label, but selection is classified as appropriate because they are judged clinically 
(see Section 8.4.3 of the Protocol) to be an appropriate selector by an independent 
panel of physician reviewers. This group is expected to be quite small. 
 
3) Incorrect Selectors. This group includes selectors who are not correct or acceptable, 
including having any of the following: 
 
a. A contraindication to the product (are pregnant or breastfeeding, has an 
allergy to one of the ingredients, or previously used ella® within the same 
menstrual cycle) 
 
Operationally defined as follows: 
• 
Pregnant:  Answered “Yes” to Section 7, Question 27 OR Section 12, 
Question 36b is “Positive”. 
• 
Breastfeeding:   Answered “Yes” to Section 7, Question 29.   
• 
Allergy:  Answered “Yes” to any part of Section 7, Question 25 or 25a. 
• 
Previous use of ella® within the same menstrual cycle:  Answered “No” to 
Section 19, Question 10d AND did not answer “Advance provision” to 
Section 5, Question 15. 
 
b. Is a man 
 
Operationally defined as follows:  Answered “Male” to Section 3, Question 3. 
 
c. Is a woman without childbearing potential. This would include all women who 
report any of the following: surgical sterilization (tubal ligation, hysterectomy, or 
bilateral oophorectomy), congenital malformation/defect, endometrial ablation, or 
postmenopausal for at least one year 
 
Operationally defined as follows:  Answered “No” to Section 7, Question 28 AND 
at least one of boxes 1-6 checked in Section 7, Question 28a. 
 
d. Has not had unprotected sex in the 5 days prior to purchase of the product and is 
not purchasing for future use 
 
Operationally defined as follows: (Answered >120 hours or >5 days to Section 5, 
Question 17 or did not answer Section 5, Question 17) AND did not answer 
“Advance provision” to Section 5, Question 15. 
 
Cell A represents a correct decision, namely consumers for whom the study product is 
right to use who choose to use it, and therefore presents very little potential adverse 
clinical consequences. 
 
Cell C, while not technically correct, is a decision that accrues no health risk, but rather 
is a missed opportunity to use the drug. Thus, these subjects are considered neither 
correct nor incorrect and are usually left out of the primary self-selection analysis. 


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The most critical self-selection decision is made by subjects who, based on their health 
status, should not use the study drug (cells B and D). Unlike an incorrect decision by 
consumers for whom this product is appropriate (cell C), an incorrect decision (cell B) by 
these consumers has potential efficacy or safety implications. Because of the point of 
sale recruitment study design, it is expected that very few subjects will be inappropriate 
for use, therefore this endpoint will be measured by the following proportion, taken from 
the self-selection table [(cell A + cell D)/(cell A + cell B + cell D)]. Again, note that this 
does not take into account cell C, as those subjects could have chosen to use the 
product, but did not (for whatever reason). 
 
Other proportions will also be presented, including the total correct selectors as 
described by the equation [(cell A + cell D) / (cell A + cell B + cell C + cell D)] and the 
typical self-selection metric, namely the proportion described by the equation [cell D/(cell 
B + cell D)]. This proportion represents a correct non-selection decision. In other words, 
this is the proportion of those who should not select the product who correctly do not 
select it. 
 
Please note, for the purposes of this study, for all subjects who qualify to purchase the 
product, self-selection will be evaluated at the time of purchase. Each purchase will be 
independently evaluated for the self-selection endpoints. Because the timing of the most 
recent episode of unprotected sex is one of the elements of appropriate use, a subject 
who does not meet the label criteria of having had unprotected sex within 120 hours of 
purchase would be categorized as an acceptable selector if it is demonstrated that she is 
purchasing for future use and meets all other requirements for correct selection. 
 
F. Actual Use: Proportion of dosing instances among user population in which HBC is not 
taken for 5 days after taking ella®. 
  
This secondary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP and the numerator includes all dosing instances in which there is no 
reported use of intermittently dosed HBC (i.e. pill, patch, or ring) for at least 5 days. The 
numerator will be defined as all dosing instances where a daily- or weekly-dosed HBC 
method (i.e., pill, patch, or ring) was not subsequently started, plus all those where a 
HBC method was started and (date of HBC method started – date of IP ingestion ≥ 5 
days).  
 
Operationally defined as follows:  Total dosing instances (denominator) is the count of all 
discrete instances of Section 19, Question 3 plus all discrete instances of Section 21, 
Question 3. Total dosing instances where there is no reported use of pill, patch or ring 
for 5 days (numerator) is the total dosing instances minus the count of all discrete 
instances where Section 19, Question 4d minus Section 19, Question 3 is <5 days plus 
discrete instances where Section 21, Question 4d minus Section 21, Question 3 is <5 
days. 
 
G. Actual Use: Proportion of dosing instances among user population associated with use 
of hormonal contraceptives in the same cycle after taking ella® in which subject reports 
using a condom (or other barrier method) every time they have sex until their next 
menstrual period.  
 


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This secondary endpoint is the proportion in which the denominator includes all dosing 
instances of the IP among those who start or restart hormonal contraception in the same 
menstrual cycle and the numerator includes dosing instances where the subject reports 
using condoms every time they have sex during the remainder of that menstrual period. 
 
 
Operationally defined as follows:  
 
Total dosing instances among those who started or restarted hormonal contraception in 
the same menstrual cycle (denominator) is the count of all discrete instances where (a 
date is given in Section 19, Question 4d AND Section 19, Question 7 is answered “No”) 
OR (a date is given in Section 19, Question 4d AND Section 19, Question 7 is answered 
“Yes” and the date in Section 19, Question 4d is before the date given in Section 19, 
Question 7a) PLUS discrete instances where (a date is given in Section 21, Question 4d 
AND Section 21, Question 7 is answered “No”) OR (a date is given in Section 21, 
Question 4d AND Section 21, Question 7 is answered “Yes” and the date in Section 21, 
Question 4d is before the data given in Section 21, Question 7a) AND (Section 19 
Question 8 was answered “Yes” or Section 21, Question 9 answered “Yes”). 
 
The numerator includes all instances of the denominator in which the subject reports use 
of a condom each time they had sex during the remainder of that menstrual cycle 
(numerator) is the total dosing instances among those who started or restarted hormonal 
contraception in the same menstrual cycle (i.e., the denominator, operationally defined 
above) minus (the count of all discrete instances where Section 19, Question 8 is 
answered “Yes” AND Section 19, Question 8c is answered “No” or Question 8d is not 
answered “Every time”) PLUS (the count of all discrete instances where Section 21, 
Question 9 is answered “Yes” AND Section 21, Question 9c is answered “No” or 
Question 9d is not answered “Every time”). 
 
This endpoint will also be presented by subject, expressed as the proportion in which the 
denominator includes all subjects who start or restart hormonal contraception in the 
same menstrual cycle on at least one occasion and the numerator includes the subjects 
who also reported using condoms each time they had sex during the remainder of that 
menstrual cycle.  
 
Operationally defined as follows:  
 
Total number of subjects who started or restarted hormonal contraception in the same 
menstrual cycle (denominator) is the count of all subjects who (provided a date in 
Section 19, Question 4d AND Section 19, Question 7 is answered “No”) OR (provided a 
date in Section 19, Question 4d AND Section 19, Question 7 is answered “Yes” and the 
date in Section 19, Question 4d is before the date given in Section 19, Question 7a) 
PLUS subjects who (provided a date in Section 21, Question 4d AND Section 21, 
Question 7 is answered “No”) OR (provided a date in Section 21, Question 4d AND 
Section 21, Question 7 is answered “Yes” and the date in Section 21, Question 4d is 
before the data given in Section 21, Question 7a) AND . 
 
The numerator includes all subjects in the denominator who report use of a condom 
each time they had sex during the remainder of that menstrual cycle who started or 
restarted hormonal contraception in the same menstrual cycle (i.e., the denominator, 


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operationally defined above) minus (the count of all subjects where Section 19, Question 
8 is answered “Yes” AND Section 19, Question 8c is answered “No” or Question 8d is 
not answered “Every time”) PLUS (the count of all subjects where Section 21, Question 
9 is answered “Yes” AND Section 21, Question 9c is answered “No” or Question 9d is 
not answered “Every time”) AND (Section 19 Question 8 was answered “Yes” or Section 
21, Question 9 answered “Yes”). 
 
H.  Actual Use: Proportion of user population who do not use the study product more than 
once in the same menstrual cycle.  
 
This secondary endpoint is the proportion in which the denominator includes all subjects 
who take at least one dose of the product (user population) and the numerator includes 
all subjects who do not use more than one dose(s) of the study product within the same 
menstrual cycle after taking the initial dose of ella®. 
 
Operationally defined as follows:  All subjects who take at least one dose of the product 
(denominator) is the count of all subjects in the user population (Section 19, Question 1 
answered “Yes” or Section 21, Question 1 answered “Yes”).  All subjects who do not use 
more than one dose(s) of the study product within the same menstrual cycle after taking 
the initial dose of ella® (numerator) is the denominator minus the count of all subjects 
who take a second dose within the same menstrual cycle as defined by any subject who 
took more than one dose of IP (Section 19, Question 2 >1 or Section 21, Question 2 >1, 
OR Section 19, Question 3 and Section 21, Question 3 represent different dates) AND 
the second reported date occurred before the date of any reported menstrual period 
(Section 19, Question 7a; Section 21, Question 7a). 
 
I. 
Self-Selection/Actual Use: Proportion of self-selection population taking one of the “ask a 
doctor or pharmacist before use” products who do not select, who select but do not use 
or who report contacting a healthcare provider or pharmacist.  
 
This secondary endpoint is the proportion defined by the denominator including all 
subjects who participate in the self-selection interview who report taking one of the “ask 
a doctor or pharmacists before use” compounds (including barbiturates, carbamazepine, 
felbamate, oxcarbazepine, phenytoin, topiramate, rifampin, griseofulvin, a prescription 
drug to treat HIV/AIDS, bosentan, or a supplement containing St. John’s Wort) and the 
numerator is all such subjects who either do not select or use or who report talking with 
a doctor or pharmacist about it use during the course of the study. 
 
Operationally defined as follows:  All subjects who participate in the self-selection 
interview who report taking one of the “ask a doctor or pharmacists before use” 
compounds (including barbiturates, carbamazepine, felbamate, oxcarbazepine, 
phenytoin, topiramate, rifampin, griseofulvin, a prescription drug to treat HIV/AIDS, 
bosentan, or a supplement containing St. John’s Wort) (denominator) as defined by 
subjects reporting any of the listed drugs in Section 13, Question 38a.  The numerator is 
all of the subjects in the denominator who are also not included in the User Population or 
who responded “Yes to Section 22, Question 11. 
 
6.4.3 Other Analyses 
The other measures are all simple proportions where the user population represents the 
denominator. 


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J. Proportion of user population who use an HBC method sometime during the past two 
menstrual cycles. 
 
Operationally defined as follows:  Denominator is count of subjects in the User 
Population.  Numerator includes all those in the denominator who answered “Yes” to 
Section 7, Question 30 OR (who answer “Yes” to Section 7, Question 32 AND who 
answer ≤56 Days ago or ≤8 Weeks ago or ≤2 Months ago to Section 7, Question 32b) or 
who answer “Yes” to Question 4 in Section 19 or Section 21. 
 
K. Proportion of user population who used any EC on more than one occasion within the 
study period. 
 
Operationally defined as follows:  Denominator is count of subjects in the User 
Population.  Numerator includes all those in the denominator who report more than one 
discrete date in iterations of Section 19, Question 3 and/or Section 21, Question 3 OR 
who answer “Yes” to Section 19, Question 5 or Section 21, Question 5. 
 
L. Proportion of user population who report becoming pregnant within the study period.  
 
This will include all pregnancies that are reported during or after completion of the study 
where conception was judged by the medical monitor to have likely taken place during 
participation, based on all that is known about the pregnancy (e.g. last menstrual period, 
medical records, ultrasound results, etc.).  Further, pregnancies will be classified as 
likely EC failure or not. 
 
 
6.4.4 Adverse Events 
Adverse event (AE) analyses will include all events which initially occurred, or worsened 
following treatment. Adverse events will be summarized by the Medical Dictionary for 
Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT) and 
classified according to their severity (mild, moderate, or severe) and relationship (related or not 
related) to study product. For the summary by severity, subjects who have multiple occurrences 
of the same AE will be classified according to the worst reported severity of the AE. Similarly, for 
the summary by relationship to the study product, the AE will be classified according to the 
worst relationship. 
7 
Changes to Planned Analysis 
In the study protocol, the label direction of “do not use for regular birth control” is included in the 
list of labeled contraindications for use in the context of evaluation of a correct selection 
decision. It was later determined that compliance with this label direction would be better 
assessed by examining the reasons for frequent purchase or use of ella® during the study 
period rather than considering this a selection issue.  Therefore, this was not included in the 
operational definition of a correct or incorrect selection decision in Section 6.4.2.1, and will 
instead be evaluated by summarizing any reasons provided for attempting to purchase more 
than three packages at one time, or more than nine packages total, over the course of the study 
period (i.e., any answers provided to the open-ended questions in Section 15/Drug Purchase 
Log).  
 


Proprietary Material of PEGUS Research, Inc. 
Do Not Copy or Distribute Without Permission 
 
PEGUS Research, Inc. 
 
 
Protocol 151032-001_Statistical Analysis Plan_Final v2.0 16 Nov 2018 
 
STA:001:TMP:01:02 (effective 03 November 2016) 
 
Page 24 of 232 
In addition, based on interactions with the FDA, several other behaviors of interest will be 
analyzed and described in the study report, such as the proportion of subjects in the user 
population who report:  
• 
using another form of EC during the study; 
o Operationally defined as levonorgestrel or a verbatim response in Section 
19, Question 5a OR Section 21, Question 5a. 
• 
using ella® (IP or prescription) multiple times in the same menstrual cycle;  
o Operationally defined as (data present in Section 22, Question 10a) OR 
any dates provided in Section 19, Question(s) 3, Section 19 Question(s) 
5c, Section 21, Question(s) 3, and Section 21, Question(s) 5c are less 
than 28 days apart.  
• 
re-starting their regular form of hormonal birth control during the study period. 
o Operationally defined as providing a date in Section 19, Question 4d or 
Section 21, Question 4d. 
8 
Datasets and Supporting Documentation 
8.1 
Datasets 
Source data (SDTM) and analysis (ADaM) datasets will conform to CDISC requirements. 
 
 
 
8.2 
Supporting Documentation 
Supporting documentation will include annotated case report forms (aCRFs) and specifications 
for SDTM and ADaM datasets.  
 
9 
Document History and Changes in the Planned Statistical Analysis 
Document 
Version / Date 
Summary of Changes 
Final SAP 
Final v1.0_31OCT2018 
N/A 
Amended SAP 
Final v2.0_16NOV2018 
Correction was made to the title of 
one of the HRA signatories.  
All references to the operational 
definition of a selector or non-
selector were updated to reflect 
that selector status was based on 
selector coding, as described in 
the protocol. The previous version 
had erroneously used a 
programmatic definition. 
Endpoint C: Section 7, Question 
27 not answered “Yes” was added 
to the operational definition. Also 
updated to include that a false 
positive on a pregnancy test due to 


Proprietary Material of PEGUS Research, Inc. 
Do Not Copy or Distribute Without Permission 
 
PEGUS Research, Inc. 
 
 
Protocol 151032-001_Statistical Analysis Plan_Final v2.0 16 Nov 2018 
 
STA:001:TMP:01:02 (effective 03 November 2016) 
 
Page 25 of 232 
a very recent abortion would be 
treated as “not pregnant” in the 
analysis. 
Correct Selectors: Section 7, 
Question 27 not answered “Yes” 
was added to the operational 
definition. Also updated to include 
that a false positive on a 
pregnancy test due to a very 
recent abortion would be treated 
as “not pregnant” in the analysis. 
In item D under Incorrect selectors 
was corrected due to errors in 
syntax and the omission of “or did 
not answer Section 5, Question 
17” 
Endpoint G: The operational 
definition for the “by subject” 
analysis of this endpoint was 
added, and the denominator 
updated to only instances that 
were associated with sex in that 
menstrual cycle.  
Other Measure J: numerator in 
operational definition was updated 
to also include “OR who answer 
“Yes” to Question 4 in Section 19 
or Section 21.” 
The descriptor “hormonal” was 
added to the third bulleted item 
under Changes to Planned 
Analysis. 
 
10 References 
1. Murphy, Peggy W.; Davis, Terry C.; Long, Sandra W.; Jackson, Robert H.; Decker, Barbara 
C. Rapid Estimate of Adult Literacy in Medicine (REALM): a quick reading test for patients. 
Journal of Reading 1993 Oct; 37(2):124-30. 
2. Davis TC, Wolf MS, Arnold CL, Byrd RS, Long SW, Springer T, Kennen E, Bocchini JA. 
Development and validation of the Rapid Estimate of Adolescent Literacy in Medicine (REALM-
Teen): a tool to screen adolescents for below-grade reading in health care settings. Pediatrics. 
2006 Dec 1;118(6):e1707-14. 
 


Proprietary Material of PEGUS Research, Inc. 
Do Not Copy or Distribute Without Permission 
 
PEGUS Research, Inc. 
 
 
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STA:001:TMP:01:02 (effective 03 November 2016) 
 
Page 26 of 232 
11 Appendices 
11.1 Final Data Collection Instrument (DCI) 


dbp 14.1.3
Annotated version.
SUBJECT NUMBER
(subnum, <subnum>)
SUBJECT NUMBER
Subject ID:
(partId, <partId>)
(String, Text)
Screening Date (DD-MMM-YYYY):
(scrDt, <scrDt>)
(Date, Text)
(dd-MMM-yyyy)
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Programming Vars (DON’T MAKE VISIBLE)
(prog, <prog>)
used for EOS Q2 (e2)
Any AE 1b contains "Talk to a HCP"
(AE1Bhcp, <AE1Bhcp>)
(String, PlainText)
AE 1b WAS ASKED
(AE1Bask, <AE1Bask>)
(String, PlainText)
Site Number
(siteNum, <siteNum>)
(String, PlainText)
Final Dispos Date Set
(DspDtSet, <DspDtSet>)
(String, PlainText)
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Sub Forms
*3  SCREENING*
*4 PURCHASE QUESTION / 5 REASON FOR PURCHASE / 6 DEMO*
*7 CURRENT / REGULAR RELEVANT MEDICATIONS AND ASSOCIATED CONDITIONS*
*8 REALM TEST*
*9 REALM TEEN TEST*
*11 INFORMED CONSENT*
*12 ENROLLMENT PREGNANCY TEST*
*13 MEDICATIONS AT ENROLLMENT*
*14 CONTACT INFORMATION AND PURCHASE TRANSACTION*
*15 DRUG PURCHASE LOG*
*16 DRUG RETURN LOG*
*17 ENROLLMENT END-OF-STUDY QUESTIONS*
*18 FINAL SUBJECT ENROLLMENT DISPOSITION*
 
Enrollment
(enroll, <enroll>)
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3  SCREENING
(screener, <screener>)
3 SCREENING
Read: Thank you for your interest in this study.  I first want
to take a minute to give you some information about our
privacy policies, so you can be assured that we are
committed to protecting your personal information.  Here is
a copy of our privacy notice for you to take with you today
that explains how we use and protect your personal
information.
  1. Interviewer: Was the written privacy notice given to the
subject?
(priv, <priv>)
(Integer, RadioCheckbox)
Yes Continue.  (1)
No Stop. (2)
Read: Next, I need to ask you some questions to see if you
qualify for the study.  The information you provide to us is
used strictly for the purposes of the study, and is stored in
secure databases that are only accessible to our
employees and other study staff who have a need to know
this information.  Demographic and health information you
provide to us may be shared with the study sponsor or
regulatory agencies, but it will always remain anonymous,
unless otherwise required by law.
 2. Do I have your permission to continue?
(perm, <perm>)
(Integer, RadioCheckbox)
Yes Continue.  (1)
No Stop. (2)
2a.  How did you hear about this study?
  Do not read answer options
  Check all that apply
(hear, <hear>)
(String, MultiCheckbox)
Front desk told me about it when I asked for emergency
contraceptive  (1)
Word of mouth (friend told me about it)  (2)
Saw a study flier at the research site  (3)
Saw a study flier somewhere else in the community  (4)
Saw an ad on social media (Facebook, Twitter,
Instagram, etc.)  (5)
Saw an ad online   (6)
Clinician referral during other clinical visit  (7)
Other: (8)
If Other, please specify:
(hearO, <hearO>)
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(String, Text)
Read: Thank you.  Now that you have been informed
about our privacy policies, let’s see if you qualify for the
study.
 3. Interviewer, please indicate subject’s gender:
  If necessary, ask: Are you male or female?
(If further clarification is needed based on gender identity
sensitivities, sites may ask: Do you have a female
reproductive system? or What was your gender
assignment at birth?)
(sex, <sex>)
(Integer, RadioCheckbox)
Female  (1)
Male (2)
4. How old are you?
 yrs.
(age, <age>)
(Integer, Text)
.
(ageRf, <ageRf>)
(Integer, RadioCheckbox)
Refused exact age – verified subject age 18 or older  (1)
Refused to answer (2)
5. Are you able to read, speak and understand English?
(suLang, <suLang>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
6. Do you normally wear corrective lenses, contacts or
glasses to read?
(glass, <glass>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 6a. If Yes to Q6: Do you currently have them with you?
(glassA, <glassA>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
6b. If No to Q6a, show mock package: Can you see well
enough without them to read text of this size?
(glassB, <glassB>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
7. Has any member of your family participated in this
study?
(famPct, <famPct>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
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8. Do you, or does anyone in your household, work…
 Ask one at a time and wait for a ‘yes’/’no’ response.
  8a. For a market research or advertising company, public
relations firm. or news organization?
(MrkAd, <MrkAd>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
8b. For a pharmacy or pharmaceutical company, or for a
medicine manufacturer?
(pharm, <pharm>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
8c. As a healthcare professional or as part of a healthcare
practice, managed care or health insurance company?
(HCP, <HCP>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
8d. Have you been trained or worked as a healthcare
professional or market research professional?
(trnHCP, <trnHCP>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
9. Have you participated in a health-related market
research or product label study in the past 12 months?
(PctMR12, <PctMR12>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
10. Have you participated in a clinical trial in the past 12
months?
(PctCLN12, <PctCLN12>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
11. Have you ever participated in a study about emergency
contraception?
(PctCont, <PctCont>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If age <18
12. Interviewer, please note:  Is the subject accompanied
by a parent/guardian?
(acPar, <acPar>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
.
Qualified Continue. (1)
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(scrQualT, <scrQualT>)
(Integer, RadioCheckbox)
.
(scrTermT, <scrTermT>)
(Integer, RadioCheckbox)
Not Qualified Read: I’m sorry, but you do not qualify to
be in the study.  There are other prescription and over-the-
counter emergency contraceptives available to you today.
Provide EC alternatives. Thank you for your interest in
participating. (1)
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4 PURCHASE QUESTION / 5 REASON FOR PURCHASE / 6 DEMO
(purchDemo, <purchDemo>)
4 SELECTION AND PURCHASE QUESTIONS
 Read: Next, I’d like you to take a look at this over-the-counter medicine packaging.  The name of this
product is ella, and it is an emergency contraceptive pill that is currently available by prescription only.  This
box is what the over-the-counter package would look like if it were to be available without a doctor’s
prescription.  I want you to imagine that you see this product on the shelf in the store where you normally
shop for over-the-counter products.
 Show the empty ella package to the subject.
 Please review and handle the product as you normally would if you were looking to purchase a new OTC
product that you haven’t used before.  You can take as much time as you need to review the information on
the package.  Please let me know when you are finished and I’ll have some questions to ask you.  Your task
is to decide whether this medicine is right for you to use and whether you would like to purchase it for your
own use.
 Give the package to the subject.
 While the subject is reading, look busy to avoid unwittingly putting pressure on him/her to read quickly or
incompletely.
 When finished reading: Keep the package for now.  You may look at it if you need to while answering my
questions.
13. Given what you have read on the label and your own
current health conditions, is this medicine okay or not okay
for you to use?
  Do not read answer options
 Check only one
(okNok, <okNok>)
(Integer, RadioCheckbox)
Okay/Yes  (1)
Not okay / No  (2)
Don’t know  (3)
Would talk to a doctor  (4)
Would talk to a pharmacist (5)
13-a.   If Q13=Would talk to a doctor OR Would talk to a
pharmacist: If you couldn’t talk to your doctor/pharmacist
and had to make a decision on your own, do you think this
medication is ok or not ok for you to use?
  Do not read answer options
 Check only one
(okNokA, <okNokA>)
Okay/Yes  (1)
Not okay / No  (2)
Don’t know (3)
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(Integer, RadioCheckbox)
13-b. Q13=Okay/Yes OR Q13a=Okay/Yes: Please tell me
why you decided this medication is right for you to use
today.
 Example neutral probing questions:
 (What things did you consider?)
 (Are there any reasons it is not OK for you to use?)
 (What things on the label did you consider?)
 Record verbatim response
(okNokB, <okNokB>)
(String, MultiLineText)
13-c.   Q13=Not okay/No or Q13a=Not okay/No: Tell me
why you think this medication is not ok for you to use
today?
 Example neutral probing questions:
 (What things did you consider?)
 (What things on the label did you consider?)
 (What things on the label helped you make this decision?)
 Record verbatim response
(okNokC, <okNokC>)
(String, MultiLineText)
13-d.   If Q13=Would talk to a doctor OR Would talk to a
pharmacist: Why would you want to talk to a
doctor/pharmacist?  What would you talk to your
doctor/pharmacist about?
 Record verbatim response
(okNokD, <okNokD>)
(String, MultiLineText)
13-e.   If Q13=Don’t know or Q13a=Don’t know: Can you
tell me why you are uncertain?
 Record verbatim response
(okNokE, <okNokE>)
(String, MultiLineText)
14.   If Q13=Okay/Yes or Q13a=Okay/Yes: Would you like
to purchase ella today for your own use? It costs $10.00
for a package containing 1 tablet.
  Do not read answer options
 Check only one
Yes  (1)
No  (2)
Don’t know (3)
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(purch, <purch>)
(Integer, RadioCheckbox)
14a. If Q14 = No: Please explain why not.
 Do not read answer options
 Check all that apply
 Probe: Probe to get as much information as possible with
neutral questions such as “are there any other reasons?”
or “anything else?”
(purchA, <purchA>)
(String, MultiCheckbox)
Cost of product  (1)
Does not have money with them  (2)
Unwilling to pay for study product / expected product to
be free  (3)
Product is not right for me / has contraindication on the
label (specify which contraindication(s))   (4)
Decided not to take emergency contraception  (5)
Decided to use a different kind of emergency
contraception  (6)
Other (specify): (7)
(specify which contraindication(s))
(purchAC, <purchAC>)
(String, Text)
If Other, please specify:
(purchAO, <purchAO>)
(String, Text)
14b. If Q14 = Don’t know: Can you please explain why you
are unsure if you would like to purchase ella?
 Probe: Probe to get as much information as possible with
neutral questions such as “are there any other reasons?”
or “anything else?”
 Record verbatim response
(purchB, <purchB>)
(String, MultiLineText)
5 REASON FOR PURCHASE
15. Why did you come to purchase emergency
contraception today?
 Do not read answer options
 Check all that apply
(whyBuy, <whyBuy>)
(String, MultiCheckbox)
I had unprotected sex/contraception failed  (1)
I want to have some at home in case I need it (advanced
provision)  (2)
Other:  specify: (3)
If Other, please specify:
(whyBuyO, <whyBuyO>)
(String, Text)
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  The next few questions ask about unprotected sex.  When I ask about unprotected sex, I am talking about
vaginal intercourse that could lead to pregnancy.  This includes sex where you did not use any birth control
or sex where your contraception failed (for example, your partner did not use a condom or a condom broke
during sex).
16.If Q15 box 1 is not checked: Have you had unprotected
sex recently?
  Do not read answer options
 Check only one
(unpSex, <unpSex>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know (3)
If Q15 =I had unprotected sex/contraception failed OR
Q16=Yes
 17. How long ago was your most recent episode of
unprotected sex?
 Do not read answer options
 Probe as needed to get best estimate
 Indicate a number and a time unit:
(recUsex, <recUsex>)
(Integer, Text)
.
(recUsexD, <recUsexD>)
(Integer, RadioCheckbox)
Hours  (1)
Days  (2)
Weeks  (3)
Months (4)
6 DEMOGRAPHICS
 Read: I am now going to ask you a few questions to help us understand the people taking our survey.
18. What is the highest level of education you have
completed?  I will read the options and you tell me which
one applies to you.
 Read answer options except ‘Refused’
 Check only one
(edu, <edu>)
(Integer, RadioCheckbox)
8th grade or less  (1)
Some high school  (2)
High school graduate, GED, or certificate  (3)
Some college or technical school  (4)
College graduate  (5)
Post-graduate degree  (6)
Refused (7)
19. Do you consider yourself Hispanic or Latino?
 Do not read answer options
 Check only one
(hisp, <hisp>)
Yes  (1)
No  (2)
Don’t know / Refused (3)
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(Integer, RadioCheckbox)
20.  Which of the following  five racial designations best
describe you?  More than one choice is acceptable.
 Read answer options except ‘Other, specify’ and
‘Refused’
 Check all that apply and avoid using Other unless
necessary
(race, <race>)
(String, MultiCheckbox)
American Indian or Alaska Native  (1)
Asian  (2)
Black or African American  (3)
Native Hawaiian or Other Pacific Islander  (4)
White  (5)
Other, specify:   (6)
Refused (7)
If Other, please specify:
(raceO, <raceO>)
(String, Text)
21. What would you estimate your annual household
income to be?  Is it:
 Read answer options except ‘Refused’ and ‘Don’t Know’
 Check only one
(income, <income>)
(Integer, RadioCheckbox)
Less than $25,000 per year   (1)
$25,000 to $34,999 per year  (2)
$35,000 to $49,999 per year  (3)
$50,000 to $74,999 per year  (4)
$75,000 to $99,999 per year  (5)
$100,000 to $149,999 per year  (6)
$150,000 or more per year  (7)
Refused  (8)
Don’t know/Not Sure (9)
22. If age <18, ask: What is the highest level of education
either of your parents has completed?  I will read the
options and you tell me which one applies to your parent.
 Read answer options except ‘Refused’ and ‘Don’t Know’
 Check only one
(eduPar, <eduPar>)
(Integer, RadioCheckbox)
8th grade or less  (1)
Some high school  (2)
High school graduate, GED, or certificate  (3)
Some college or technical school  (4)
College graduate  (5)
Post-graduate degree  (6)
Refused  (7)
Don’t know/Not sure (8)
23. What is your height?
Feet
(htF, <htF>)
(Integer, Text)
Inches
(htI, <htI>)
(Integer, Text)
.
(htRef, <htRef>)
Refused (1)
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(String, MultiCheckbox)
24. What is your weight?
Pounds
(wt, <wt>)
(Integer, Text)
.
(wtRef, <wtRef>)
(String, MultiCheckbox)
Refused (1)
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7 CURRENT / REGULAR RELEVANT MEDICATIONS AND ASSOCIATED CONDITIONS
(crMeds, <crMeds>)
7 CURRENT / REGULAR RELEVANT MEDICATIONS AND ASSOCIATED CONDITIONS
 SECTION 7 - FEMALES ONLY
 Read: Now I have a few questions about your health and some medicines you may be taking.  For some of
these I will ask if you are taking them right now or if you have ever taken them.  Don’t be shy to ask me to
repeat a question if you aren’t sure which I have asked about.
Point out the active ingredient on the mock package:
 25. Do you have a known allergy to the active ingredient
in ella, ulipristal acetate?
 Do not read answer options
 Check only one
(alElla, <alElla>)
(Integer, RadioCheckbox)
Yes   (1)
No (2)
Point out the inactive ingredients on the mock package:
  25a. Do you have a known allergy to any of these inactive
ingredients?
   Allow subject to review the list on the package and check
‘yes’ or ‘no’ for each sub-question.
   Read answer options
  A Croscarmellose sodium
(alEllaA, <alEllaA>)
(Integer, RadioCheckbox)
Yes   (1)
No (2)
B Lactose monohydrate
(alEllaB, <alEllaB>)
(Integer, RadioCheckbox)
Yes   (1)
No (2)
C Magnesium stearate
(alEllaC, <alEllaC>)
(Integer, RadioCheckbox)
Yes   (1)
No (2)
D Povidone
(alEllaD, <alEllaD>)
(Integer, RadioCheckbox)
Yes   (1)
No (2)
26. Show calendar:  On what date did you start your last
(dd-MMM-yyyy)
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menstrual period? If unable to give exact date:  What is
your best guess about when your last period started?
Enter date (DD-MMM-YYYY):
(lstM, <lstM>)
(Date, Text)
.
(lstMUK, <lstMUK>)
(Integer, RadioCheckbox)
Unknown   (1)
Has not had a first menstrual period (premenarchal) (2)
26a. If Unknown checked in Q26: Can you tell me
approximately how many weeks ago you started your last
menstrual period?
weeks ago
(lstM2, <lstM2>)
(Integer, Text)
.
(lstM2A, <lstM2A>)
(Integer, RadioCheckbox)
Other: specify    (1)
Don’t know   (2)
Has not had a first menstrual period (premenarchal) (3)
If Other, please specify:
(lstM2AO, <lstM2AO>)
(String, Text)
27. Are you currently pregnant?
 Do not read answer options
 Check only one
(prego, <prego>)
(Integer, RadioCheckbox)
Yes   (1)
No    (2)
Don’t know (3)
27a. If Q27=Yes: How do you know that you are pregnant?
  Do not read answer options
  Check all that apply
(pregA, <pregA>)
(String, MultiCheckbox)
I missed periods / My period is late  (1)
Positive pregnancy test  (2)
Doctor told me I’m pregnant  (3)
Other: specify (4)
If Other, please specify:
(pregAO, <pregAO>)
(String, Text)
27b. If Q27=Don’t know: Can you tell me why you say you
don’t know, or what you mean by that?  Do you have a
reason to believe that you may already be pregnant?
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 Record verbatim response, probe to find out if they have
reasons in addition to the recent unprotected intercourse
for which they came seeking EC to think they may be
pregnant
(pregB, <pregB>)
(String, MultiLineText)
28. Is it physically possible for you to become pregnant?
(posPg, <posPg>)
(Integer, RadioCheckbox)
Yes   (1)
No    (2)
Don’t know (3)
28a. If Q28=No: Can you tell me why you cannot physically
become pregnant?
 Interviewer:  If subject responds “No” to Q28, but provides
a birth control method as a reason below, correct Q28 to
‘Yes’ and proceed to Q29.
  Do not read answer options
  Check all that apply
(posPgA, <posPgA>)
(String, MultiCheckbox)
Tubal ligation  (1)
Hysterectomy  (2)
Postmenopausal (for at least one year)  (3)
Bilateral oophorectomy (ovariectomy)  (4)
Congenital malformation/ defect  (5)
Endometrial ablation  (6)
Other: please specify (7)
If Other, please specify:
(posPgAO, <posPgAO>)
(String, Text)
29. Are you currently breastfeeding?
 Do not read answer options
 Check only one
(brstFd, <brstFd>)
(Integer, RadioCheckbox)
Yes   (1)
No    (2)
Don’t know (3)
30. Right now, are you using a birth control pill, vaginal
ring, patch, implant, or injection or an IUD (intra-uterine
device)?
 Do not read answer options
 Check only one
(bc, <bc>)
(Integer, RadioCheckbox)
Yes   (1)
No    (2)
Don’t know (3)
30a. If Q30=Yes: Which of those are you currently using?
  Do not read answer options
  Check all that apply
(bcA, <bcA>)
Birth control pill  (1)
Vaginal ring  (2)
Birth control patch  (3)
Implant  (4)
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(String, MultiCheckbox)
Injection  (5)
IUD  (6)
Don’t know / Not sure  (7)
Other: (8)
If Other, please specify:
(bcAO, <bcAO>)
(String, Text)
30b. If Q30=Yes: Which of those have you ever used?
  Do not read answer options
  Check all that apply
(bcB, <bcB>)
(String, MultiCheckbox)
Birth control pill  (1)
Vaginal ring  (2)
Birth control patch  (3)
Implant  (4)
Injection  (5)
IUD  (6)
Don’t know / Not sure  (7)
Other: (8)
If Other, please specify:
(bcBO, <bcBO>)
(String, Text)
31. Right now do you use any other method or protection
to prevent pregnancy?
(oMth, <oMth>)
(Integer, RadioCheckbox)
Yes   (1)
No    (2)
Don’t know (3)
31a. If Q31=Yes: What are you using?
  Do not read answer options
  Check all that apply
(oMthA, <oMthA>)
(String, MultiCheckbox)
Male condoms  (01)
Female condoms  (02)
Diaphragm  (03)
Sponge  (04)
Spermicide  (05)
Partner vasectomy/Partner is sterile  (06)
Rhythm method  (07)
Withdrawal  (08)
Abstinence  (09)
Partner is not male  (10)
Don’t know / Not sure  (11)
Other: (12)
If Other, please specify:
(oMthAO, <oMthAO>)
(String, Text)
32. If Q30=No: Have you ever used a birth control pill,
Yes   (1)
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vaginal ring, patch, implant, or injection or an IUD (intra-
uterine device)?
(evrBC, <evrBC>)
(Integer, RadioCheckbox)
No    (2)
Don’t know (3)
32a. If Q32=Yes: Which of those have you used in the
past?
  Do not read answer options
  Check all that apply
(evrBCA, <evrBCA>)
(String, MultiCheckbox)
Birth control pill  (1)
Vaginal ring  (2)
Birth control patch  (3)
Implant  (4)
Injection  (5)
IUD  (6)
Don’t know / Not sure  (7)
Other: (8)
If Other, please specify:
(evrBCAO, <evrBCAO>)
(String, Text)
32b.  If Q32=Yes: When was the last time you used one of
those birth control methods?
If subject is unsure, probe to get their best guess
Indicate a number and a time unit:
(evrBCn, <evrBCn>)
(Integer, Text)
.
(evrBCd, <evrBCd>)
(Integer, RadioCheckbox)
Days ago  (1)
Weeks ago   (2)
Months ago  (3)
Years ago (4)
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8 REALM TEST
(realm, <realm>)
8 REALM TEST
 Read:  It would be helpful for us to get an idea of what medical words you are familiar with.  What I need
you to do is look at this list of words, beginning here.
 Point to the first word in List 1 on the purple card.
 Say all of the words out loud.  If you come to a word you don’t know, you can sound it out or just skip it and
go on.
 Give subject the purple card.
 a. Click on the “Correct” box for each word the subject pronounces correctly.
 b. Click on the “Not Correct” box for each word the subject does not attempt or mispronounces.
  c. Make sure there is an entry for every word; there must be no blanks.
 d. If the subject refused to take the REALM Test, click on the box just above the beginning of the test.
Subject refused to take REALM Test
(rlmRf, <rlmRf>)
(Integer, RadioCheckbox)
Refused (1)
fat:
(fat, <fat>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
flu:
(flu, <flu>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
pill:
(pill, <pill>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
dose:
(dose, <dose>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
eye:
(eye, <eye>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
stress:
Correct (1)
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(stress, <stress>)
(Integer, RadioCheckbox)
Not Correct (0)
smear:
(smear, <smear>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
nerves:
(nerves, <nerves>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
germs:
(germs, <germs>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
meals:
(meals, <meals>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
disease:
(disease, <disease>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
cancer:
(cancer, <cancer>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
caffeine:
(caffeine, <caffeine>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
attack:
(attack, <attack>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
kidney:
(kidney, <kidney>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
hormones:
(hormones, <hormones>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
herpes:
(herpes, <herpes>)
Correct (1)
Not Correct (0)
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(Integer, RadioCheckbox)
seizure:
(seizure, <seizure>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
bowel:
(bowel, <bowel>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
asthma:
(asthma, <asthma>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
rectal:
(rectal, <rectal>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
incest:
(incest, <incest>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
fatigue:
(fatigue, <fatigue>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
pelvic:
(pelvic, <pelvic>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
jaundice:
(jaundice, <jaundice>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
infection:
(infect, <infect>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
exercise:
(exercise, <exercise>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
behavior:
(behavior, <behavior>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
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prescription:
(prescrip, <prescrip>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
notify:
(notify, <notify>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
gallbladder:
(gall, <gall>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
calories:
(calories, <calories>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
depression:
(depress, <depress>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
miscarriage:
(miscar, <miscar>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
pregnancy:
(preg, <preg>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
arthritis:
(arth, <arth>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
nutrition:
(nutrit, <nutrit>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
menopause:
(meno, <meno>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
appendix:
(appendix, <appendix>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
abnormal:
Correct (1)
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(abnormal, <abnormal>)
(Integer, RadioCheckbox)
Not Correct (0)
syphilis:
(syph, <syph>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
hemorrhoids:
(hemorr, <hemorr>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
nausea:
(nausea, <nausea>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
directed:
(directed, <directed>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
allergic:
(allergic, <allergic>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
menstrual:
(menstr, <menstr>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
testicle:
(testicle, <testicle>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
colitis:
(colitis, <colitis>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
emergency:
(emerg, <emerg>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
medication:
(medic, <medic>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
occupation:
(occup, <occup>)
Correct (1)
Not Correct (0)
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(Integer, RadioCheckbox)
sexually:
(sexually, <sexually>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
alcoholism:
(alcohol, <alcohol>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
irritation:
(irritat, <irritat>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
constipation:
(constipa, <constipa>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
gonorrhea:
(gonorr, <gonorr>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
inflammatory:
(inflam, <inflam>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
diabetes:
(diab, <diab>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
hepatitis:
(hepa, <hepa>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
antibiotics:
(antibi, <antibi>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
diagnosis:
(diagnos, <diagnos>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
potassium:
(potas, <potas>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
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anemia:
(anemia, <anemia>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
obesity:
(obesity, <obesity>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
osteoporosis:
(osteo, <osteo>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
impetigo:
(impetigo, <impetigo>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
REALM Score:
(lit, <lit>)
(String, PlainText)
You have left one or more words blank.  DO NOT SAVE.
Check for missing words
(noRealm, <noRealm>)
(String, PlainText)
REALM Complete
(yesRealm, <yesRealm>)
(String, PlainText)
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9 REALM TEEN TEST
(realmT, <realmT>)
9 REALM TEEN TEST
 Read:  It would be helpful for us to get an idea of what medical words you are familiar with.  What I need
you to do is look at this list of words, beginning here.
 Point to the first word in List 1 on the green card.
 Say all of the words out loud.  If you come to a word you don’t know, you can sound it out or just skip it and
go on.
 a. Give subject the green card.
 b. Click on the “Correct” box for each word the subject pronounces correctly.
 c. Click on the “Not Correct” box for each word the subject does not attempt or mispronounces.
 d. Make sure there is an entry for every word; there must be no blanks.
 e. If the subject refused to take the REALM Teen Test, click on the box just above the beginning of the test.
Subject refused to take REALM-Teen Test
(rlmtRf, <rlmtRf>)
(Integer, RadioCheckbox)
Refused (1)
eye:
(rt1, <rt1>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
pill:
(rt2, <rt2>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
fat:
(rt3, <rt3>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
skin:
(rt4, <rt4>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
throat:
(rt5, <rt5>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
blood:
(rt6, <rt6>)
Correct (1)
Not Correct (0)
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(Integer, RadioCheckbox)
weight:
(rt7, <rt7>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
stress:
(rt8, <rt8>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
death:
(rt9, <rt9>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
liquid:
(rt10, <rt10>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
disease:
(rt11, <rt11>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
drug:
(rt12, <rt12>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
mouth:
(rt13, <rt13>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
ounce:
(rt14, <rt14>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
heart:
(rt15, <rt15>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
risks:
(rt16, <rt16>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
diet:
(rt17, <rt17>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
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teaspoon:
(rt18, <rt18>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
period:
(rt19, <rt19>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
cancer:
(rt20, <rt20>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
stomach:
(rt21, <rt21>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
headache:
(rt22, <rt22>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
fever:
(rt23, <rt23>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
pimple:
(rt24, <rt24>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
virus:
(rt25, <rt25>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
calories:
(rt26, <rt26>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
allergy:
(rt27, <rt27>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
marijuana:
(rt28, <rt28>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
pelvic:
Correct (1)
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(rt29, <rt29>)
(Integer, RadioCheckbox)
Not Correct (0)
asthma:
(rt30, <rt30>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
emergency:
(rt31, <rt31>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
infection:
(rt32, <rt32>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
exercise:
(rt33, <rt33>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
medicine:
(rt34, <rt34>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
violence:
(rt35, <rt35>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
prevention:
(rt36, <rt36>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
suicide:
(rt37, <rt37>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
depression:
(rt38, <rt38>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
prescription:
(rt39, <rt39>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
abnormal:
(rt40, <rt40>)
Correct (1)
Not Correct (0)
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(Integer, RadioCheckbox)
injury:
(rt41, <rt41>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
ointment:
(rt42, <rt42>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
seizure:
(rt43, <rt43>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
diabetes:
(rt44, <rt44>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
nutrition:
(rt45, <rt45>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
alcoholism:
(rt46, <rt46>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
antibiotic:
(rt47, <rt47>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
complications:
(rt48, <rt48>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
delinquency:
(rt49, <rt49>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
penicillin:
(rt50, <rt50>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
puberty:
(rt51, <rt51>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
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menstrual:
(rt52, <rt52>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
pneumonia:
(rt53, <rt53>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
constipation:
(rt54, <rt54>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
diagnosis:
(rt55, <rt55>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
nausea:
(rt56, <rt56>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
acne:
(rt57, <rt57>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
anemia:
(rt58, <rt58>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
hepatitis:
(rt59, <rt59>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
adolescent:
(rt60, <rt60>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
bulimia:
(rt61, <rt61>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
fatigue:
(rt62, <rt62>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
anorexia:
Correct (1)
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(rt63, <rt63>)
(Integer, RadioCheckbox)
Not Correct (0)
tetanus:
(rt64, <rt64>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
bronchial:
(rt65, <rt65>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
obesity:
(rt66, <rt66>)
(Integer, RadioCheckbox)
Correct (1)
Not Correct (0)
Realm score:
(litT, <litT>)
(String, PlainText)
You have left one or more words blank.  DO NOT SAVE.
Check for missing words
(noRealmT, <noRealmT>)
(String, PlainText)
REALM Complete
(ysRealmT, <ysRealmT>)
(String, PlainText)
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11 INFORMED CONSENT
(ic, <ic>)
11 INFORMED CONSENT
 Read: Thank you.  Now, I would like you to read this Informed Consent Document that explains all about
your participation in this study today.  Please read it very carefully; take as much time as you need.  If you
have any questions, please ask me.  Also, please don’t sign anything until we have a chance to talk after
you’ve read it.
33. Interviewer: Was the subject allowed to ask questions
about the study and were questions addressed and
answered to the subject’s satisfaction prior to obtaining
written informed consent?
(alAsk, <alAsk>)
(Integer, RadioCheckbox)
Yes:  Continue   (1)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
34. Interviewer: Did the subject (or parent/guardian of an
adolescent subject) sign the informed consent document?
(IC, <IC>)
(Integer, RadioCheckbox)
Yes:  Continue   (1)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
34a. If Yes to Q34: Record the date of consent signature.
(DD/MMM/YYYY)
(icDT, <icDT>)
(Date, Text)
(dd-MMM-yyyy)
34b. If Yes to Q34: Record first initial and last name of
study staff member conducting consent, as qualified per
the Site Signature and Responsibility Log.
(icIntl, <icIntl>)
(String, Text)
35.Interviewer, if subject is ≤17 years old or enrolls with a
parent/guardian present: Did the adolescent subject sign
assent on the informed consent document?
(assPG, <assPG>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
35.Interviewer, if subject is ≤17 years old or enrolls with a
parent/guardian present: Did the adolescent subject sign
assent on the informed consent document?
(ass18, <ass18>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
35.Interviewer, if subject is ≤14 years old or enrolls with a
Yes: Continue  (1)
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parent/guardian present: Did the adolescent subject sign
assent on the informed consent document?
(ass15, <ass15>)
(Integer, RadioCheckbox)
No STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
35.Interviewer, if subject is ≤15 years old or enrolls with a
parent/guardian present: Did the adolescent subject sign
assent on the informed consent document?
(ass16, <ass16>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
35.Interviewer, if subject is ≤16 years old or enrolls with a
parent/guardian present: Did the adolescent subject sign
assent on the informed consent document?
(ass17, <ass17>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
35a. If Yes to Q35: Record the date of assent signature.
(DD/MMM/YYYY)
(assDT, <assDT>)
(Date, Text)
(dd-MMM-yyyy)
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12 ENROLLMENT PREGNANCY TEST
(enPreg, <enPreg>)
12 ENROLLMENT PREGNANCY TEST
 Read: As we just talked about while going over the study information, I will now need you to provide a urine
sample.
36. Interviewer: Was the pregnancy test conducted?
(enPregT, <enPregT>)
(Integer, RadioCheckbox)
Yes: Continue   (1)
No: (2)
Specify:
(enPregTs, <enPregTs>)
(Integer, RadioCheckbox)
Test malfunctioned or results unclear.  (1)
Subject unable to provide urine sample.  (2)
Subject declined to take test. STOP here.  Subject does
not qualify to continue. (3)
36a. If Yes to Q36: Record the date of test.
   (DD/MMM/YYYY)
(enPregTa, <enPregTa>)
(Date, Text)
(dd-MMM-yyyy)
Q36b If Yes to Q36=Yes: What was the result of the
pregnancy test?
(enPregTb, <enPregTb>)
(Integer, RadioCheckbox)
Positive:  Subject does not qualify to continue, continue
to Q37  (1)
Negative (2)
 36c.If test result is negative: Did the subject request the
result?
(enPregTc, <enPregTc>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If Q36b=Positive, read: Your urine sample was used to
conduct a pregnancy test which came back with a positive
result.
 37. Given what you have read on the label and this new
information about your current health conditions, is this
medicine okay or not okay for you to use?
 Do not read answer options
 Check only one
(enPrg37, <enPrg37>)
(Integer, RadioCheckbox)
Okay/Yes  (1)
Not okay / No  (2)
Don’t know  (3)
Would talk to a doctor  (4)
Would talk to a pharmacist  (5)
Other, specify: (6)
If Other, please specify:
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(enPrg37O, <enPrg37O>)
(String, Text)
 37a. If Q37=Would talk to a doctor OR Would talk to a
pharmacist: If you couldn’t talk to your doctor/pharmacist
and had to make a decision on your own, do you think this
medication is ok or not ok for you to use?
 Do not read answer options
 Check only one
(enPrg37a, <enPrg37a>)
(Integer, RadioCheckbox)
Okay/Yes  (1)
Not okay / No  (2)
Don’t know (3)
37b. Q37=Okay/Yes OR Q37a=Okay/Yes: Please tell me
why you decided this medication is right for you to use
today.
 Example neutral probing questions:
 (What things did you consider?)
 (Are there any reasons it is not OK for you to use?)
 (What things on the label did you consider?)
 Record verbatim response
(enPrg37b, <enPrg37b>)
(String, MultiLineText)
37c. Q37=Not okay/No or Q37a=Not okay/No: Please tell
me why you think this medication is not ok for you to use
today?
 Example neutral probing questions:
 (What things did you consider?)
 (What things on the label did you consider?)
 (What things on the label helped you make this decision?)
 Record verbatim response
(enPrg37c, <enPrg37c>)
(String, MultiLineText)
37d. If Q37=Don’t know or Q37a=Don’t know: Can you tell
me why you are uncertain?
 Record verbatim response
(enPrg37d, <enPrg37d>)
(String, MultiLineText)
 37e. If Q37=Okay/Yes or Q37a=Okay/Yes: Would you still
like to purchase ella today for your own use?
 Do not read answer options
 Check only one
Yes  (1)
No  (2)
Don’t know (3)
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(enPrg37e, <enPrg37e>)
(Integer, RadioCheckbox)
37f. If Q37e=No: Please explain why not.
 Do not read answer options
 Check all that apply
 Probe: Probe to get as much information as possible with
neutral questions such as “are there any other reasons?”
or “anything else?”
(enPrg37f, <enPrg37f>)
(String, MultiCheckbox)
Should not use if already pregnant  (1)
Does not have money with them  (2)
Unwilling to pay for study product / expected product to
be free  (3)
Product is not right for me / has contraindication on the
label (specify which contraindication(s))  (4)
Decided not to take emergency contraception  (5)
Decided to use a different kind of emergency
contraception  (6)
Other (specify): (7)
 please specify:
(enP37fC, <enP37fC>)
(String, Text)
If Other, please specify:
(enP37fO, <enP37fO>)
(String, Text)
37g. If Q37e=Don’t know: Can you please explain why you
are unsure if you would like to purchase ella?
 Probe: Probe to get as much information as possible with
neutral questions such as “are there any other reasons?”
or “anything else?”
 Record verbatim response
(enPrg37g, <enPrg37g>)
(String, MultiLineText)
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13 MEDICATIONS AT ENROLLMENT
(medEn, <medEn>)
13 MEDICATIONS AT ENROLLMENT
38. Are you currently taking any prescription medications,
or are there over-the-counter or herbal products that you
take regularly?
 Do not read answer options
 Check only one
(presc, <presc>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know (3)
38a. If Q38=Yes: What are you currently taking?  Why are
you taking that?
 List each medication and the associated indication
 1
(med1, <med1>)
(String, Text)
Indication:
(med1I, <med1I>)
(String, Text)
2
(med2, <med2>)
(String, Text)
Indication:
(med2I, <med2I>)
(String, Text)
3
(med3, <med3>)
(String, Text)
Indication:
(med3I, <med3I>)
(String, Text)
4
(med4, <med4>)
(String, Text)
Indication:
(med4I, <med4I>)
(String, Text)
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5
(med5, <med5>)
(String, Text)
Indication:
(med5I, <med5I>)
(String, Text)
6
(med6, <med6>)
(String, Text)
Indication:
(med6I, <med6I>)
(String, Text)
7
(med7, <med7>)
(String, Text)
Indication:
(med7I, <med7I>)
(String, Text)
8
(med8, <med8>)
(String, Text)
Indication:
(med8I, <med8I>)
(String, Text)
9
(med9, <med9>)
(String, Text)
Indication:
(med9I, <med9I>)
(String, Text)
10
(med10, <med10>)
(String, Text)
Indication:
(med10I, <med10I>)
(String, Text)
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14 CONTACT INFORMATION AND PURCHASE TRANSACTION
(conPurch, <conPurch>)
14 CONTACT INFORMATION AND PURCHASE TRANSACTION
Collect contact information for subjects who qualify for the use period and who sign consent.  Also, collect
contact information for a person who does not live with the subject, but will know how to contact the subject.
Or for an adolescent subject with a parent/guardian present, collect the parent’s information as an alternate
contact.
 Read: I would now like to collect some contact information.  Your contact information is necessary for the
purposes of conducting the telephone follow-up interviews and compensating you for those interviews.
39. Interviewer: Did the subject provide contact
information?
(contact, <contact>)
(Integer, RadioCheckbox)
Yes: Continue (1)
No  STOP here. Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
Read: The study product costs $10.00 for a package of 1
tablet.
 40. Study product is only for use by study subjects.  Do
you confirm that you will not allow anyone else to use your
study product?
 Do not read answer options
 Check only one
(elsUse, <elsUse>)
(Integer, RadioCheckbox)
Yes: Continue (1)
No  STOP here. Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating.  (2)
Read: Would you like to purchase the product today?
 41. Did the subject purchase the study drug?
(purch2, <purch2>)
(Integer, RadioCheckbox)
Yes – Continue to Drug Purchase log to conduct and
record the purchase transaction  (1)
No (2)
41a. If Q41=No: Why did you decide not  to purchase this
product today?
  Do not read answer options
  Check all that apply
 Probe: Probe to get as much information as possible with
neutral questions such as “are there any other reasons?”
or “anything else?”
(noPur, <noPur>)
(String, MultiCheckbox)
Cost of product  (1)
Does not have money with them  (2)
Unwilling to pay for study product / expected product to
be free  (3)
Product is not right for me / has contraindication on the
label (Specify which contraindication(s))   (4)
Decided not to take emergency contraception  (5)
Decided to use a different kind of emergency
contraception  (6)
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Other (specify) (7)
Specify which contraindication:
(noPurC, <noPurC>)
(String, Text)
If Other, please specify:
(noPurO, <noPurO>)
(String, Text)
If Q41=No: End of Enrollment Interview Script for Non-
purchasers:
 Read: Thank you for your interest in this study, but you do
not qualify to continue.  If you feel you need emergency
contraception, it is advised you speak to a doctor or
pharmacist about your options, or look into an over-the-
counter emergency contraceptive.  Thanks again for your
participation and have a nice day.
 Verify that script was read and compensate subject
(verSc2, <verSc2>)
(Integer, RadioCheckbox)
Yes (1)
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15 DRUG PURCHASE LOG
(dpl, <dpl>)
15 DRUG PURCHASE LOG
 Instructions:
 • Use one entry for each package purchased
 • Enter date of purchase
 • Write subject number on the outer carton and inner foil blister sheet of each package purchased.
Pack 1
(pack1, <pack1>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack1Dt, <pack1Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 2
(pack2, <pack2>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack2Dt, <pack2Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 3
(pack3, <pack3>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack3Dt, <pack3Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 4
(pack4, <pack4>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack4Dt, <pack4Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 5
(pack5, <pack5>)
(Integer, RadioCheckbox)
 (1)
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Date of Purchase
(pack5Dt, <pack5Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 6
(pack6, <pack6>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack6Dt, <pack6Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 7
(pack7, <pack7>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack7Dt, <pack7Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 8
(pack8, <pack8>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack8Dt, <pack8Dt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 9
(pack9, <pack9>)
(Integer, RadioCheckbox)
 (1)
Date of Purchase
(pack9Dt, <pack9Dt>)
(Date, Text)
(dd-MMM-yyyy)
Total number of packages purchased:
(totPacks, <totPacks>)
(Integer, PlainText)
(expression, pack1 +
pack2 +
pack3 +
pack4 +
pack5 +
pack6 +
pack7 +
pack8 +
pack9)
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Attempted to purchase more than 3 packages at any one
time during the study.
(att3, <att3>)
(Integer, RadioCheckbox)
 (1)
Number of packages requested on one occasion:
(att3num, <att3num>)
(Integer, Text)
If attempted to purchase more than 3 packages at any one
encounter:  I can only sell you 3 packages at any one time.
Can you tell me why you wanted to purchase more than 3
packages today?
(att3Why, <att3Why>)
(String, MultiLineText)
Attempted to purchase more than 9 packages over the
course of the study.
(att9, <att9>)
(Integer, RadioCheckbox)
 (1)
Number of packages requested in total over the course of
the study:
(att9num, <att9num>)
(Integer, Text)
If attempted to purchase more than 9 packages over the
course of study participation:  I can only sell you a total of
9 packages over the course of the study.  Can you tell me
why you wanted to purchase more than 9 packages over
the course of the study?
(att9Why, <att9Why>)
(String, MultiLineText)
Continue to Enrollment Disposition and Compensation
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16 DRUG RETURN LOG
(dr, <dr>)
16 DRUG RETURN LOG
 Drug Return Instructions:
 • Use one entry for each package returned
 • Enter date of return
Pack 1 Date of Drug Return
(pack1RDt, <pack1RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 2 Date of Drug Return
(pack2RDt, <pack2RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 3 Date of Drug Return
(pack3RDt, <pack3RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 4 Date of Drug Return
(pack4RDt, <pack4RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 5 Date of Drug Return
(pack5RDt, <pack5RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 6 Date of Drug Return
(pack6RDt, <pack6RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 7 Date of Drug Return
(pack7RDt, <pack7RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 8 Date of Drug Return
(pack8RDt, <pack8RDt>)
(Date, Text)
(dd-MMM-yyyy)
Pack 9 Date of Drug Return
(pack9RDt, <pack9RDt>)
(Date, Text)
(dd-MMM-yyyy)
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17 ENROLLMENT END-OF-STUDY QUESTIONS
(enEOS, <enEOS>)
17 ENROLLMENT END-OF-STUDY QUESTIONS
  Read: You do not qualify to purchase and use this product, because it is not medically suitable for you for
one or more reasons.  I’d like to ask you some additional questions about why you wanted to purchase.
42. If ((Q13 or Q13a=Yes)) and male (Q3=Male): You are
male, and this product is only for females.  Why did you
say this product was right for you?
(enEMale, <enEMale>)
(String, MultiLineText)
43. If ((Q13 or Q13a=Yes)) and allergic (Q25=Yes or
Q25a=Yes to any of A, B, C or D): You told me that you
are allergic to one or more of the ingredients of this
product.  Why did you say that it was right for you to use?
(enEalrg, <enEalrg>)
(String, MultiLineText)
44. If [((Q13 or Q13a=Yes)) and pregnant (Q27=Yes)] OR
(Q37=Okay/yes):  You told me that you are pregnant and
that this product would be ok for you to use.  The label for
this product says ‘do not use if you are already pregnant’
because the product is intended to prevent pregnancy.
Why did you say that it was right for you?
(enEpreg, <enEpreg>)
(String, MultiLineText)
45. If ((Q13 or Q13a=Yes)) and breastfeeding (Q29=Yes):
You told me that you are breastfeeding.  The label says
that this product should not be used while breastfeeding.
Why did you say that it was right for you to purchase?
(enEBF, <enEBF>)
(String, MultiLineText)
Read: Thank you for your interest in this study, but you do
not qualify to continue.  If you feel you need emergency
contraception, it is advised you speak to a doctor or
pharmacist about your options, or look into an over-the-
counter emergency contraceptive.  Thanks again for your
participation and have a nice day.
Yes (1)
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 Verify that script was read and compensate subject
(verSc3, <verSc3>)
(Integer, RadioCheckbox)
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18 FINAL SUBJECT ENROLLMENT DISPOSITION
(enDISP, <enDISP>)
18 FINAL SUBJECT ENROLLMENT DISPOSITION / COMPENSATION
  Interviewer: Verify correct disposition, enter any other/specify.
  Check only one
.
(enDisp1, <enDisp1>)
(Integer, RadioCheckbox)
Disqualified during screening (1)
.
(enDisp2, <enDisp2>)
(Integer, RadioCheckbox)
Qualified after screening but did not start the interview
(1)
.
(enDisp3, <enDisp3>)
(Integer, RadioCheckbox)
Disqualified during enrollment interview, not allowed to
purchase (1)
.
(enDisp4, <enDisp4>)
(Integer, RadioCheckbox)
Started but did not complete the interview (specify why
not): (1)
.
(enDisp5, <enDisp5>)
(Integer, RadioCheckbox)
Completed interview: Eligible to purchase but did not
purchase (1)
.
(enDisp6, <enDisp6>)
(Integer, RadioCheckbox)
Completed interview and purchased (1)
.
(enDisp7, <enDisp7>)
(Integer, RadioCheckbox)
Other (1)
specify why not
(enDspI, <enDspI>)
(String, Text)
If Other, please specify:
(enDspO, <enDspO>)
(String, Text)
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Read: Thank you for participating in this study.  Your
compensation for participation is a $75 prepaid Visa card.
Please note that it expires in a few months.
 Verify that script was read and compensate subject
(vrCmpS, <vrCmpS>)
(Integer, RadioCheckbox)
Yes (1)
Please record the last 5 digits from the card used to
compensate the subject, complete the compensation
acknowledgment form with subject signature to document
receipt:
(cardVer, <cardVer>)
(Integer, Text)
Please record the last 5 digits from the card used to
compensate the subject, complete the compensation
acknowledgment form with subject signature to document
receipt:   :
(cardVerV, <cardVerV>)
(Integer, Text)
For purchasers, read: As we discussed when we went over
the consent document, after you complete the telephone
interviews in two and six weeks that are part of this study,
you can choose to be compensated with a digital prepaid
Visa card that you will receive in your email.  Once you’ve
received it in your email you can either use it for online
purchases or over the phone, or you can choose to have a
physical card sent to you.
 Are you okay with your payment being sent to the email
you gave us?
  If No: Ok, then you will receive your prepaid Visa card in
the mail.
  Read: If you have any questions, please call the number
listed on page one of your consent document.  If you need
to come back to purchase any additional study medication,
please call first to make sure a member of the study staff
will be available.
Yes  (1)
No (2)
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 For enrolled subjects, provide them with enrollment
compensation, pink copy of the informed consent, the
purchased study drug, pre-paid return envelope, home
pregnancy test, and administrative information card with
subject number recorded on all materials.  Show subject all
materials and explain use.
   Thank you again for your participation. Have a nice day.
(prcPay, <prcPay>)
(Integer, RadioCheckbox)
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Sub Forms
*19 NURSE FOLLOW-UP INTERVIEW (WEEK 2)*
*20 CONCOMITANT MEDICATIONS*
*21 NURSE FOLLOW-UP INTERVIEW (WEEK 6)*
*22 END-OF-STUDY OR EARLY TERMINATION INTERVIEW*
*23 END OF STUDY PREGNANCY TEST RESULTS*
*24 AE / SAE / EIU FORMS*
*Pregnancy Collection Form (emergency contraception)*
*25 FINAL SUBJECT DISPOSITION – ENROLLED SUBJECTS*
 
Use
(use, <use>)
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19 NURSE FOLLOW-UP INTERVIEW (WEEK 2)
(fu2, <fu2>)
19 NURSE FOLLOW-UP INTERVIEW (WEEK 2)
 Read: Hello, my name is _______________. I am a nurse from PEGUS Research calling about the study
that you enrolled in at (study site) on (date of enrollment).  I have some questions about your use of the ella
emergency contraception pill(s) that you purchased at that time. This phone interview usually takes about 20
minutes and you will be paid for your time.  May I go ahead now? (If no, ask when would be a good time to
call back)
Subject Number:
(w2Sub, <w2Sub>)
(String, Text)
Date of interview:
(w2DT, <w2DT>)
(Date, Text)
(dd-MMM-yyyy)
Read: The following questions are about your use of the
study medicine ella.  I will also be asking a few questions
about unprotected sex.  The next few questions ask about
unprotected sex.  When I ask about unprotected sex, I am
talking about heterosexual vaginal sexual intercourse that
could lead to pregnancy.  This includes sex where you did
not use any birth control or sex where your contraception
failed (for example, your partner did not use a condom or a
condom broke during sex).
   1. Have you taken the ella tablet (any of the ella tablets)
that you purchased as part of this study?
(w2Tak, <w2Tak>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
1a. If Q1=No: Why haven’t you taken ella?
 Do not read responses
 Check all that apply
(w2TakN, <w2TakN>)
(String, MultiCheckbox)
I haven’t needed it / Didn’t have unprotected sex   (1)
Bought it for advance provision / for future use in case
the need arises  (2)
I decided against it  (3)
I started my period  (4)
I forgot / misplaced it  (5)
Other (6)
If Other, please specify:
(w2TakNo, <w2TakNo>)
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(String, Text)
2. How many different times did you take ella?
  times
(w2Tab, <w2Tab>)
(Integer, Text)
.
(w2TabA, <w2TabA>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w2TabAo, <w2TabAo>)
(String, Text)
3. On what date did you first take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt1, <w23Dt1>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T1, <w23T1>)
(Integer, Text)
.
(w23TA1, <w23TA1>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo1, <w23TAo1>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U1, <w23U1>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA1, <w23UA1>)
Did not have unprotected sex (1)
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(Integer, RadioCheckbox)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA11, <w23UA11>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C1, <w23C1>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co1, <w23Co1>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w241, <w241>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w24A1, <w24A1>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B1, <w24B1>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C1, <w24C1>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
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How many were missed durring the week before taking
ella?
(w24CN1, <w24CN1>)
(Integer, Text)
If Other, please specify:
(w24Co1, <w24Co1>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt1, <w24DDt1>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D1, <w24D1>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E1, <w24E1>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo1, <w24Eo1>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt2, <w23Dt2>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
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(w23T2, <w23T2>)
(Integer, Text)
.
(w23TA2, <w23TA2>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo2, <w23TAo2>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U2, <w23U2>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA2, <w23UA2>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA12, <w23UA12>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C2, <w23C2>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co2, <w23Co2>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w242, <w242>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
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 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w24A2, <w24A2>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B2, <w24B2>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C2, <w24C2>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
ella?
(w24CN2, <w24CN2>)
(Integer, Text)
If Other, please specify:
(w24Co2, <w24Co2>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt2, <w24DDt2>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D2, <w24D2>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
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4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E2, <w24E2>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo2, <w24Eo2>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt3, <w23Dt3>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T3, <w23T3>)
(Integer, Text)
.
(w23TA3, <w23TA3>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo3, <w23TAo3>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U3, <w23U3>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA3, <w23UA3>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
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3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA13, <w23UA13>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C3, <w23C3>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co3, <w23Co3>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w243, <w243>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w24A3, <w24A3>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B3, <w24B3>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C3, <w24C3>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
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ella?
(w24CN3, <w24CN3>)
(Integer, Text)
If Other, please specify:
(w24Co3, <w24Co3>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt3, <w24DDt3>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D3, <w24D3>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E3, <w24E3>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo3, <w24Eo3>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt4, <w23Dt4>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T4, <w23T4>)
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(Integer, Text)
.
(w23TA4, <w23TA4>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo4, <w23TAo4>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U4, <w23U4>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA4, <w23UA4>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA14, <w23UA14>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C4, <w23C4>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co4, <w23Co4>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w244, <w244>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
Birth control pill  (1)
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you using?
 Do not read responses
 Check all that apply
(w24A4, <w24A4>)
(String, MultiCheckbox)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B4, <w24B4>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C4, <w24C4>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
ella?
(w24CN4, <w24CN4>)
(Integer, Text)
If Other, please specify:
(w24Co4, <w24Co4>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt4, <w24DDt4>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D4, <w24D4>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
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4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E4, <w24E4>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo4, <w24Eo4>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt5, <w23Dt5>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T5, <w23T5>)
(Integer, Text)
.
(w23TA5, <w23TA5>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo5, <w23TAo5>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U5, <w23U5>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA5, <w23UA5>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
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3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA15, <w23UA15>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C5, <w23C5>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co5, <w23Co5>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w245, <w245>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w24A5, <w24A5>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B5, <w24B5>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C5, <w24C5>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
07-Feb-2018
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ella?
(w24CN5, <w24CN5>)
(Integer, Text)
If Other, please specify:
(w24Co5, <w24Co5>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt5, <w24DDt5>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D5, <w24D5>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E5, <w24E5>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo5, <w24Eo5>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt6, <w23Dt6>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T6, <w23T6>)
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(Integer, Text)
.
(w23TA6, <w23TA6>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo6, <w23TAo6>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U6, <w23U6>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA6, <w23UA6>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA16, <w23UA16>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C6, <w23C6>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co6, <w23Co6>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w246, <w246>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
Birth control pill  (1)
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you using?
 Do not read responses
 Check all that apply
(w24A6, <w24A6>)
(String, MultiCheckbox)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B6, <w24B6>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C6, <w24C6>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
ella?
(w24CN6, <w24CN6>)
(Integer, Text)
If Other, please specify:
(w24Co6, <w24Co6>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt6, <w24DDt6>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D6, <w24D6>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
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4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E6, <w24E6>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo6, <w24Eo6>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt7, <w23Dt7>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T7, <w23T7>)
(Integer, Text)
.
(w23TA7, <w23TA7>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo7, <w23TAo7>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U7, <w23U7>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA7, <w23UA7>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
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3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA17, <w23UA17>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C7, <w23C7>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co7, <w23Co7>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w247, <w247>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w24A7, <w24A7>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B7, <w24B7>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C7, <w24C7>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
07-Feb-2018
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ella?
(w24CN7, <w24CN7>)
(Integer, Text)
If Other, please specify:
(w24Co7, <w24Co7>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt7, <w24DDt7>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D7, <w24D7>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E7, <w24E7>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo7, <w24Eo7>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt8, <w23Dt8>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T8, <w23T8>)
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(Integer, Text)
.
(w23TA8, <w23TA8>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo8, <w23TAo8>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U8, <w23U8>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA8, <w23UA8>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA18, <w23UA18>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C8, <w23C8>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co8, <w23Co8>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w248, <w248>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
Birth control pill  (1)
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you using?
 Do not read responses
 Check all that apply
(w24A8, <w24A8>)
(String, MultiCheckbox)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B8, <w24B8>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C8, <w24C8>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
ella?
(w24CN8, <w24CN8>)
(Integer, Text)
If Other, please specify:
(w24Co8, <w24Co8>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt8, <w24DDt8>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D8, <w24D8>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
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4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E8, <w24E8>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo8, <w24Eo8>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w23Dt9, <w23Dt9>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w23T9, <w23T9>)
(Integer, Text)
.
(w23TA9, <w23TA9>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w23TAo9, <w23TAo9>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w23U9, <w23U9>)
(Date, Text)
(dd-MMM-yyyy)
.
(w23UA9, <w23UA9>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
07-Feb-2018
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3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w23UA19, <w23UA19>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w23C9, <w23C9>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w23Co9, <w23Co9>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w249, <w249>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w24A9, <w24A9>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w24B9, <w24B9>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w24C9, <w24C9>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed durring the week before taking
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ella?
(w24CN9, <w24CN9>)
(Integer, Text)
If Other, please specify:
(w24Co9, <w24Co9>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w24DDt9, <w24DDt9>)
(Date, Text)
(dd-MMM-yyyy)
.
(w24D9, <w24D9>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w24E9, <w24E9>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w24Eo9, <w24Eo9>)
(String, Text)
5. Since you enrolled in the study on (date of enrollment),
have you taken any other form of emergency
contraception, other than the ella you purchased as part of
this study?
(w25, <w25>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
5a. If Q5=Yes: What other kind of emergency
contraception did you take?
 Do not read responses
prescription ulipristal acetate (ella), not the study drug
(1)
levonorgestrel (Plan B, My Way, Next Choice)   (2)
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 Check all that apply
(w25A, <w25A>)
(String, MultiCheckbox)
Other: (3)
If Other, please specify:
(w25Ao, <w25Ao>)
(String, Text)
5b. If Q5a Box 1 checked: How many times did you take
ella or ulipristal acetate that you got from somewhere other
than this study? Times
(w25BN, <w25BN>)
(Integer, Text)
.
(w25B, <w25B>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w25Bo, <w25Bo>)
(String, Text)
5c. If Q5a Box 1 checked: On what date did you first take
ella that you got from somewhere other than this study?
 Enter date:_____________ (MM/DD/YYYY)
(w25C1, <w25C1>)
(Date, Text)
(dd-MMM-yyyy)
.
(w25C1dk, <w25C1dk>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember (1)
5d. How many ella tablets did you take on that date?
tablets
(w25DN1, <w25DN1>)
(Integer, Text)
.
(w25D1, <w25D1>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w25Do1, <w25Do1>)
(String, Text)
5c. If Q5a Box 1 checked: On what date did you next take
ella that you got from somewhere other than this study?
(dd-MMM-yyyy)
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 Enter date:_____________ (MM/DD/YYYY)
(w25C2, <w25C2>)
(Date, Text)
5d. How many ella tablets did you take on that date?
tablets
(w25DN2, <w25DN2>)
(Integer, Text)
.
(w25D2, <w25D2>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w25Do2, <w25Do2>)
(String, Text)
5c. If Q5a Box 1 checked: On what date did you next take
ella that you got from somewhere other than this study?
 Enter date:_____________ (MM/DD/YYYY)
(w25C3, <w25C3>)
(Date, Text)
(dd-MMM-yyyy)
5d. How many ella tablets did you take on that date?
tablets
(w25DN3, <w25DN3>)
(Integer, Text)
.
(w25D3, <w25D3>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w25Do3, <w25Do3>)
(String, Text)
6. If Q5=Yes AND Q5a =levonogestrel or other: How many
times have you taken any other form of emergency
contraception not including ella, either from this study or
another source, since (date of enrollment).
  Times
(w26N, <w26N>)
(Integer, Text)
.
(w26, <w26>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
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If Other, please specify:
(w26O, <w26O>)
(String, Text)
7. Since you enrolled in the study on (date of enrollment),
have you had a menstrual period?
(w27, <w27>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
7a.  If Q7=Yes: To the best of your recollection, what day
did that menstrual period start?
 Enter date, encourage best estimate if uncertain
  (MM/DD/YYYY)
(w27A, <w27A>)
(Date, Text)
(dd-MMM-yyyy)
.
(w27dk, <w27dk>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember (1)
Read: The next few questions I’ll ask about sexual
intercourse.  When I ask about sexual intercourse, I am
talking about heterosexual vaginal sex (not oral sex or
same-gender partner sex).
  If Q1=Yes
 8. Between when you took the first dose of ella from this
study and (Q7=Yes (date of last period) OR Q7=No
(today’s date)), did you have sexual intercourse?
(w28, <w28>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
8a.  If Q8=Yes: Did you use anything or take anything to
prevent pregnancy when you had sex during that time
(after you first took the study drug ella and (before your
period started) or (now))?
(w28A, <w28A>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
8b.  If Q8a=Yes: What are all the birth control methods you
were using to prevent pregnancy when you had sex during
that time (after you first took the study drug ella and
(before your period started) or (now))?
 Do not read responses
Condoms  (01)
Diaphragm  (02)
Sponge  (03)
Spermicide  (04)
Birth control pills/patch/vaginal ring  (05)
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 Check all that apply
(w28B, <w28B>)
(String, MultiCheckbox)
Long-acting contraceptives (implant/injection/IUD)  (06)
Partner wasn’t male  (07)
Didn’t have vaginal intercourse  (08)
Withdrawal  (09)
Natural family planning/rhythm method  (10)
Don’t know / Not sure / Don’t remember  (11)
Other (specify): (12)
If Other, please specify:
(w28Bo, <w28Bo>)
(String, Text)
8c.  If ((Q8=Yes AND Q8a=No) OR (Q8b Condoms or
Diaphragm or Sponge)): Have you used a condom or other
barrier method  of birth control (like a sponge or
diaphragm) during intercourse since you first used ella that
you got from this study?
(w28C, <w28C>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
8d.  If (Q8b=Condoms or Diaphragm or Sponge) OR
Q8c=Yes: How often did you use (a
condom/diaphragm/sponge) when you had sex after first
using ella and (before your menstrual period started) or
(now)?
(w28D, <w28D>)
(Integer, RadioCheckbox)
Every time  (1)
Most of the time (more than 50% of the time)  (2)
Some of the time (less than 50% of the time) (3)
 The next question is about unprotected sex.  The next few
questions ask about unprotected sex.  When I ask about
unprotected sex, I am talking about heterosexual vaginal
sexual intercourse that could lead to pregnancy.  This
includes sex where you did not use any birth control or sex
where your contraception failed (for example, your partner
did not use a condom or a condom broke during sex).
  If Q1=Yes
 9. Have you had unprotected sex since enrolling in the
study?
(w29, <w29>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
10. Before participating in this study, had you ever used an
emergency contraceptive?
Yes  (1)
No (2)
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(w210, <w210>)
(Integer, RadioCheckbox)
10a. If Q10=Yes: What kind of emergency contraception
did you take?
 Do not read responses
 Check all that apply
(w210a, <w210a>)
(String, MultiCheckbox)
prescription ulipristal acetate (ella), not the study drug
(1)
levonorgestrel (Plan B, My Way, Next Choice)   (2)
Other: (3)
If Other, please specify:
(w210aO, <w210aO>)
(String, Text)
10b. If Q10a Box 1 not checked: Have you ever used ella
before participating in this study?
(w210b, <w210b>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure   (3)
Other (4)
If Other, please specify:
(w210bO, <w210bO>)
(String, Text)
 10c. If Q10a Box 1 or Q10b Box 1 checked:  Before you
enrolled in this study when did you last use ella?
(w210cN, <w210cN>)
(Integer, Text)
.
(w210cD, <w210cD>)
(Integer, RadioCheckbox)
Days ago  (1)
Weeks ago  (2)
Months ago  (3)
Years ago  (4)
Don’t know / Not sure /Don’t remember  (5)
Other: (6)
If Other, please specify:
(w210cO, <w210cO>)
(String, Text)
10d. If Q10c Box 1 or 2 checked: Did you have a period
between taking that dose of ella and the study medicine
ella that you got as part of this study?
(w210d, <w210d>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure   (3)
Other (4)
If Other, please specify:
(w210dO, <w210dO>)
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(String, Text)
Adverse Event Trigger Questions
 These questions should be asked of everybody to determine if any adverse events need to be recorded.
 Now I’m going to ask you some questions about any other health problems you may have had during the
study.
  Since you enrolled in the ella study, have you been to the doctor for any reason not already discussed?
 Since you enrolled in the ella study, have you developed any new medical problems not already discussed?
 Since you enrolled in the ella study, have you been to a hospital as a patient for any reason?
  Also consider new medications or changes in medications reported.
 Based on the responses to all questions go to the Adverse Events Form and complete as necessary.
Complete Concomitant Medication Form
 11. Since you enrolled in this study on (date of
enrollment), have you started taking any new medications?
(w211, <w211>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
Tab Total from week 2 interview:
(totTabs, <totTabs>)
(Integer, PlainText)
(expression, w23T1 +
w23T2 +
w23T3 +
w23T4 +
w23T5 +
w23T6 +
w23T7+
w23T8 +
w23T9 +
w25DN1 +
w25DN2 +
w25DN3)
Read: That concludes our telephone interview for today.
Your compensation    for this interview will come to you in
the (mail in the next 2 weeks) or (as an e-card in your
email in the next week).  A nurse from PEGUS Research
will contact you again in approximately one month for your
final interview.  Remember that the pregnancy test that you
Not contacted  (1)
Refused Interview (2)
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were given at the site will need to be taken just before that
interview.  Thank you for your time and have a nice day.
(w2NC, <w2NC>)
(Integer, RadioCheckbox)
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20 CONCOMITANT MEDICATIONS
(cm, <cm>)
20 CONCOMITANT MEDICATIONS
Please review all Enrollment medications and update as necessary.
1
(c1, <c1>)
(String, Text)
Indication:
(c1I, <c1I>)
(String, Text)
Ongoing?
(c1A, <c1A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c1aAE, <c1aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c1aeRef, <c1aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c1SDt, <c1SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c1EDt, <c1EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c1Ds, <c1Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c1Rt, <c1Rt>)
(String, Text)
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If Associated with an AE = Yes Causal relationship
(c1Caus, <c1Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
2
(c2, <c2>)
(String, Text)
Indication:
(c2I, <c2I>)
(String, Text)
Ongoing?
(c2A, <c2A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c2aAE, <c2aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c2aeRef, <c2aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c2SDt, <c2SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c2EDt, <c2EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c2Ds, <c2Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c2Rt, <c2Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c2Caus, <c2Caus>)
Yes  (1)
No (2)
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(Integer, RadioCheckbox)
3
(c3, <c3>)
(String, Text)
Indication:
(c3I, <c3I>)
(String, Text)
Ongoing?
(c3A, <c3A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c3aAE, <c3aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c3aeRef, <c3aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c3SDt, <c3SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c3EDt, <c3EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c3Ds, <c3Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c3Rt, <c3Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c3Caus, <c3Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
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4
(c4, <c4>)
(String, Text)
Indication:
(c4I, <c4I>)
(String, Text)
Ongoing?
(c4A, <c4A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c4aAE, <c4aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c4aeRef, <c4aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c4SDt, <c4SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c4EDt, <c4EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c4Ds, <c4Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c4Rt, <c4Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c4Caus, <c4Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
5
(c5, <c5>)
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(String, Text)
Indication:
(c5I, <c5I>)
(String, Text)
Ongoing?
(c5A, <c5A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c5aAE, <c5aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c5aeRef, <c5aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c5SDt, <c5SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c5EDt, <c5EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c5Ds, <c5Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c5Rt, <c5Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c5Caus, <c5Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
6
(c6, <c6>)
(String, Text)
Indication:
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(c6I, <c6I>)
(String, Text)
Ongoing?
(c6A, <c6A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c6aAE, <c6aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c6aeRef, <c6aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c6SDt, <c6SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c6EDt, <c6EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c6Ds, <c6Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c6Rt, <c6Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c6Caus, <c6Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
7
(c7, <c7>)
(String, Text)
Indication:
(c7I, <c7I>)
(String, Text)
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Ongoing?
(c7A, <c7A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c7aAE, <c7aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c7aeRef, <c7aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c7SDt, <c7SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c7EDt, <c7EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c7Ds, <c7Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c7Rt, <c7Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c7Caus, <c7Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
8
(c8, <c8>)
(String, Text)
Indication:
(c8I, <c8I>)
(String, Text)
Ongoing?
(c8A, <c8A>)
Yes  (1)
No (2)
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(Integer, RadioCheckbox)
Associated with an AE? (specify)
(c8aAE, <c8aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c8aeRef, <c8aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c8SDt, <c8SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c8EDt, <c8EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c8Ds, <c8Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c8Rt, <c8Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c8Caus, <c8Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
9
(c9, <c9>)
(String, Text)
Indication:
(c9I, <c9I>)
(String, Text)
Ongoing?
(c9A, <c9A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
Yes  (1)
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(c9aAE, <c9aAE>)
(Integer, RadioCheckbox)
No (2)
If yes, select:
(c9aeRef, <c9aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c9SDt, <c9SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c9EDt, <c9EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c9Ds, <c9Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c9Rt, <c9Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c9Caus, <c9Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
10
(c10, <c10>)
(String, Text)
Indication:
(c10I, <c10I>)
(String, Text)
Ongoing?
(c10A, <c10A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c10aAE, <c10aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
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If yes, select:
(c10aeRef, <c10aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c10SDt, <c10SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c10EDt, <c10EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c10Ds, <c10Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c10Rt, <c10Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c10Caus, <c10Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Reviewed all Enrollment medications and updated as
necessary?
(cRevMed, <cRevMed>)
(Integer, RadioCheckbox)
Y  (1)
N (2)
Read:  What new medicines are you taking?  Why did you
start taking that medicine?
(cRepNMed, <cRepNMed>)
(Integer, RadioCheckbox)
Report New Medicine (1)
11
(c11, <c11>)
(String, Text)
Indication:
(c11I, <c11I>)
(String, Text)
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Ongoing?
(c11A, <c11A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c11aAE, <c11aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c11aeRef, <c11aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c11SDt, <c11SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c11EDt, <c11EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c11Ds, <c11Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c11Rt, <c11Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c11Caus, <c11Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c11bnr, <c11bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
12
(c12, <c12>)
(String, Text)
Indication:
(c12I, <c12I>)
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(String, Text)
Ongoing?
(c12A, <c12A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c12aAE, <c12aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c12aeRef, <c12aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c12SDt, <c12SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c12EDt, <c12EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c12Ds, <c12Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c12Rt, <c12Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c12Caus, <c12Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c12bnr, <c12bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
13
(c13, <c13>)
(String, Text)
Indication:
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(c13I, <c13I>)
(String, Text)
Ongoing?
(c13A, <c13A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c13aAE, <c13aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c13aeRef, <c13aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c13SDt, <c13SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c13EDt, <c13EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c13Ds, <c13Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c13Rt, <c13Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c13Caus, <c13Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c13bnr, <c13bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
14
(c14, <c14>)
(String, Text)
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Indication:
(c14I, <c14I>)
(String, Text)
Ongoing?
(c14A, <c14A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c14aAE, <c14aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c14aeRef, <c14aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c14SDt, <c14SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c14EDt, <c14EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c14Ds, <c14Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c14Rt, <c14Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c14Caus, <c14Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c14bnr, <c14bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
15
(c15, <c15>)
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(String, Text)
Indication:
(c15I, <c15I>)
(String, Text)
Ongoing?
(c15A, <c15A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c15aAE, <c15aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c15aeRef, <c15aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c15SDt, <c15SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c15EDt, <c15EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c15Ds, <c15Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c15Rt, <c15Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c15Caus, <c15Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c15bnr, <c15bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
16
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(c16, <c16>)
(String, Text)
Indication:
(c16I, <c16I>)
(String, Text)
Ongoing?
(c16A, <c16A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c16aAE, <c16aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c16aeRef, <c16aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c16SDt, <c16SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c16EDt, <c16EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c16Ds, <c16Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c16Rt, <c16Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c16Caus, <c16Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c16bnr, <c16bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
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17
(c17, <c17>)
(String, Text)
Indication:
(c17I, <c17I>)
(String, Text)
Ongoing?
(c17A, <c17A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c17aAE, <c17aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c17aeRef, <c17aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c17SDt, <c17SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c17EDt, <c17EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c17Ds, <c17Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c17Rt, <c17Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c17Caus, <c17Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c17bnr, <c17bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
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18
(c18, <c18>)
(String, Text)
Indication:
(c18I, <c18I>)
(String, Text)
Ongoing?
(c18A, <c18A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c18aAE, <c18aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c18aeRef, <c18aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c18SDt, <c18SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c18EDt, <c18EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c18Ds, <c18Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c18Rt, <c18Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c18Caus, <c18Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
(c18bnr, <c18bnr>)
Yes  (1)
No (2)
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(Integer, RadioCheckbox)
19
(c19, <c19>)
(String, Text)
Indication:
(c19I, <c19I>)
(String, Text)
Ongoing?
(c19A, <c19A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c19aAE, <c19aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c19aeRef, <c19aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c19SDt, <c19SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c19EDt, <c19EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c19Ds, <c19Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c19Rt, <c19Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c19Caus, <c19Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Baseline med not reported at enrollment?
Yes  (1)
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(c19bnr, <c19bnr>)
(Integer, RadioCheckbox)
No (2)
20
(c20, <c20>)
(String, Text)
Indication:
(c20I, <c20I>)
(String, Text)
Ongoing?
(c20A, <c20A>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Associated with an AE? (specify)
(c20aAE, <c20aAE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If yes, select:
(c20aeRef, <c20aeRef>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Associated with an AE = Yes
Start date:
(c20SDt, <c20SDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes AND If Ongoing = No
End date:
(c20EDt, <c20EDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Associated with an AE = Yes
 Daily dose:
(c20Ds, <c20Ds>)
(String, Text)
If Associated with an AE = Yes
 Route (e.g. iv, po)
(c20Rt, <c20Rt>)
(String, Text)
If Associated with an AE = Yes Causal relationship
(c20Caus, <c20Caus>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
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Baseline med not reported at enrollment?
(c20bnr, <c20bnr>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
.
(barb, <barb>)
(Integer, RadioCheckbox)
Subject reported taking barbiturates, carbamazepine,
felbamate, oxcarbazepine, phenytoin, or topiramate (1)
.
(rifa, <rifa>)
(Integer, RadioCheckbox)
Subject reported taking rifampin (1)
.
(grise, <grise>)
(Integer, RadioCheckbox)
Subject reported taking griseofulvin (1)
.
(bosn, <bosn>)
(Integer, RadioCheckbox)
Subject reported taking bosentan (1)
.
(stJohn, <stJohn>)
(Integer, RadioCheckbox)
Subject reported taking St. John’s Wort or any herbal
product containing hypericum perforatum (1)
.
(HIVm, <HIVm>)
(Integer, RadioCheckbox)
Subject reported taking medicine to treat HIV/AIDS (1)
.
(nonAbove, <nonAbove>)
(Integer, RadioCheckbox)
Subject did not report taking any of the above
medications (1)
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21 NURSE FOLLOW-UP INTERVIEW (WEEK 6)
(fu6, <fu6>)
21 NURSE FOLLOW-UP INTERVIEW (WEEK 6)
 Read: Hello, my name is _______________. I am a nurse from PEGUS Research calling about the study
that you enrolled in at (study site) on (date of enrollment).  I have some questions about your use of the ella
emergency contraception pill that you purchased at that time. This phone interview usually takes about 20
minutes and you will be paid for your time.  May I go ahead now?
 (If no, ask when would be a good time to call back)
Subject Number:
(w6Sub, <w6Sub>)
(String, Text)
Date of interview:
(w6DT, <w6DT>)
(Date, Text)
(dd-MMM-yyyy)
Read: The following questions are about your use of the study medicine, ella.  I will also be asking a few
questions about unprotected sex.  The next few questions ask about unprotected sex.  When I ask about
unprotected sex, I am talking about heterosexual vaginal sexual intercourse that could lead to pregnancy.
This includes sex where you did not use any birth control or sex where your contraception failed (for
example, your partner did not use a condom or a condom broke during sex).
   If Q1 from Week 2 = Yes AND (number of tablets
purchased – number of tablets previously reported to have
been taken (total of Q3a in week-2 interview) =0):  (Skip to
Q5)
  If Q1 from Week 2 = No OR if Week 2 interview not
completed, ask Q1-6, then skip to Q8:
  1. Have you taken the ella tablet (any of the ella tablets)
that you purchased as part of this study?
(w6Tak, <w6Tak>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
1a. If Q1=No: Why haven’t you taken ella?
 Do not read responses
 Check all that apply
(w6TakN, <w6TakN>)
(String, MultiCheckbox)
I haven’t needed it / Didn’t have unprotected sex   (1)
Bought it for advance provision / for future use in case
the need arises  (2)
I decided against it  (3)
I started my period  (4)
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I forgot / misplaced it  (5)
Other (6)
If Other, please specify:
(w6TakNo, <w6TakNo>)
(String, Text)
(If Q1=No or blank Skip to Q5)
2. How many different times did you take ella?
  times
(w6Tab, <w6Tab>)
(Integer, Text)
.
(w6TabA, <w6TabA>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w6TabAo, <w6TabAo>)
(String, Text)
3. On what date did you first take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc.)
 Enter date:_____________ (MM/DD/YYYY)
(w63Dt1, <w63Dt1>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w63T1, <w63T1>)
(Integer, Text)
.
(w63TA1, <w63TA1>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo1, <w63TAo1>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
(dd-MMM-yyyy)
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 Enter date:  (MM/DD/YYY)
(w63U1, <w63U1>)
(Date, Text)
.
(w63UA1, <w63UA1>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA11, <w63UA11>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C1, <w63C1>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co1, <w63Co1>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w641, <w641>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A1, <w64A1>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B1, <w64B1>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
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 Check all that apply
(w64C1, <w64C1>)
(String, MultiCheckbox)
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN1, <w64CN1>)
(Integer, Text)
If Other, please specify:
(w64Co1, <w64Co1>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w64DDt1, <w64DDt1>)
(Date, Text)
(dd-MMM-yyyy)
.
(w64D1, <w64D1>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E1, <w64E1>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo1, <w64Eo1>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
(dd-MMM-yyyy)
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 Enter date:_____________ (MM/DD/YYYY)
(w63Dt2, <w63Dt2>)
(Date, Text)
3a. How many tablets did you take on that date?
  tablets
(w63T2, <w63T2>)
(Integer, Text)
.
(w63TA2, <w63TA2>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo2, <w63TAo2>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w63U2, <w63U2>)
(Date, Text)
(dd-MMM-yyyy)
.
(w63UA2, <w63UA2>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA12, <w63UA12>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C2, <w63C2>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co2, <w63Co2>)
(String, Text)
07-Feb-2018
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4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w642, <w642>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A2, <w64A2>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B2, <w64B2>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w64C2, <w64C2>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN2, <w64CN2>)
(Integer, Text)
If Other, please specify:
(w64Co2, <w64Co2>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(dd-MMM-yyyy)
07-Feb-2018
109 / 206
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(w64DDt2, <w64DDt2>)
(Date, Text)
.
(w64D2, <w64D2>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E2, <w64E2>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo2, <w64Eo2>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w63Dt3, <w63Dt3>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w63T3, <w63T3>)
(Integer, Text)
.
(w63TA3, <w63TA3>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo3, <w63TAo3>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
(dd-MMM-yyyy)
07-Feb-2018
110 / 206
Librella AUT 151032-001_aDCI_Release to Production 07Feb2018_Blood Collection and Liver Testing DCI_Final v1.0_05Feb2018 and Liver FU DCI_Final v1.1_02Feb2018


 Enter date:  (MM/DD/YYY)
(w63U3, <w63U3>)
(Date, Text)
.
(w63UA3, <w63UA3>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA13, <w63UA13>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C3, <w63C3>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co3, <w63Co3>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w643, <w643>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A3, <w64A3>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B3, <w64B3>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
07-Feb-2018
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 Check all that apply
(w64C3, <w64C3>)
(String, MultiCheckbox)
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN3, <w64CN3>)
(Integer, Text)
If Other, please specify:
(w64Co3, <w64Co3>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w64DDt3, <w64DDt3>)
(Date, Text)
(dd-MMM-yyyy)
.
(w64D3, <w64D3>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E3, <w64E3>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo3, <w64Eo3>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
(dd-MMM-yyyy)
07-Feb-2018
112 / 206
Librella AUT 151032-001_aDCI_Release to Production 07Feb2018_Blood Collection and Liver Testing DCI_Final v1.0_05Feb2018 and Liver FU DCI_Final v1.1_02Feb2018


 Enter date:_____________ (MM/DD/YYYY)
(w63Dt4, <w63Dt4>)
(Date, Text)
3a. How many tablets did you take on that date?
  tablets
(w63T4, <w63T4>)
(Integer, Text)
.
(w63TA4, <w63TA4>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo4, <w63TAo4>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w63U4, <w63U4>)
(Date, Text)
(dd-MMM-yyyy)
.
(w63UA4, <w63UA4>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA14, <w63UA14>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C4, <w63C4>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co4, <w63Co4>)
(String, Text)
07-Feb-2018
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4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w644, <w644>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A4, <w64A4>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B4, <w64B4>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w64C4, <w64C4>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN4, <w64CN4>)
(Integer, Text)
If Other, please specify:
(w64Co4, <w64Co4>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(dd-MMM-yyyy)
07-Feb-2018
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(w64DDt4, <w64DDt4>)
(Date, Text)
.
(w64D4, <w64D4>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E4, <w64E4>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo4, <w64Eo4>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w63Dt5, <w63Dt5>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w63T5, <w63T5>)
(Integer, Text)
.
(w63TA5, <w63TA5>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo5, <w63TAo5>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
(dd-MMM-yyyy)
07-Feb-2018
115 / 206
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 Enter date:  (MM/DD/YYY)
(w63U5, <w63U5>)
(Date, Text)
.
(w63UA5, <w63UA5>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA15, <w63UA15>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C5, <w63C5>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co5, <w63Co5>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w645, <w645>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A5, <w64A5>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B5, <w64B5>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
07-Feb-2018
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 Check all that apply
(w64C5, <w64C5>)
(String, MultiCheckbox)
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN5, <w64CN5>)
(Integer, Text)
If Other, please specify:
(w64Co5, <w64Co5>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w64DDt5, <w64DDt5>)
(Date, Text)
(dd-MMM-yyyy)
.
(w64D5, <w64D5>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E5, <w64E5>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo5, <w64Eo5>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
(dd-MMM-yyyy)
07-Feb-2018
117 / 206
Librella AUT 151032-001_aDCI_Release to Production 07Feb2018_Blood Collection and Liver Testing DCI_Final v1.0_05Feb2018 and Liver FU DCI_Final v1.1_02Feb2018


 Enter date:_____________ (MM/DD/YYYY)
(w63Dt6, <w63Dt6>)
(Date, Text)
3a. How many tablets did you take on that date?
  tablets
(w63T6, <w63T6>)
(Integer, Text)
.
(w63TA6, <w63TA6>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo6, <w63TAo6>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w63U6, <w63U6>)
(Date, Text)
(dd-MMM-yyyy)
.
(w63UA6, <w63UA6>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA16, <w63UA16>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C6, <w63C6>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co6, <w63Co6>)
(String, Text)
07-Feb-2018
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4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w646, <w646>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A6, <w64A6>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B6, <w64B6>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w64C6, <w64C6>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN6, <w64CN6>)
(Integer, Text)
If Other, please specify:
(w64Co6, <w64Co6>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(dd-MMM-yyyy)
07-Feb-2018
119 / 206
Librella AUT 151032-001_aDCI_Release to Production 07Feb2018_Blood Collection and Liver Testing DCI_Final v1.0_05Feb2018 and Liver FU DCI_Final v1.1_02Feb2018


(w64DDt6, <w64DDt6>)
(Date, Text)
.
(w64D6, <w64D6>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E6, <w64E6>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo6, <w64Eo6>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w63Dt7, <w63Dt7>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w63T7, <w63T7>)
(Integer, Text)
.
(w63TA7, <w63TA7>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo7, <w63TAo7>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
(dd-MMM-yyyy)
07-Feb-2018
120 / 206
Librella AUT 151032-001_aDCI_Release to Production 07Feb2018_Blood Collection and Liver Testing DCI_Final v1.0_05Feb2018 and Liver FU DCI_Final v1.1_02Feb2018


 Enter date:  (MM/DD/YYY)
(w63U7, <w63U7>)
(Date, Text)
.
(w63UA7, <w63UA7>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA17, <w63UA17>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C7, <w63C7>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co7, <w63Co7>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w647, <w647>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A7, <w64A7>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B7, <w64B7>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
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 Check all that apply
(w64C7, <w64C7>)
(String, MultiCheckbox)
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN7, <w64CN7>)
(Integer, Text)
If Other, please specify:
(w64Co7, <w64Co7>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w64DDt7, <w64DDt7>)
(Date, Text)
(dd-MMM-yyyy)
.
(w64D7, <w64D7>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E7, <w64E7>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo7, <w64Eo7>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
(dd-MMM-yyyy)
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 Enter date:_____________ (MM/DD/YYYY)
(w63Dt8, <w63Dt8>)
(Date, Text)
3a. How many tablets did you take on that date?
  tablets
(w63T8, <w63T8>)
(Integer, Text)
.
(w63TA8, <w63TA8>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo8, <w63TAo8>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
 Enter date:  (MM/DD/YYY)
(w63U8, <w63U8>)
(Date, Text)
(dd-MMM-yyyy)
.
(w63UA8, <w63UA8>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA18, <w63UA18>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C8, <w63C8>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co8, <w63Co8>)
(String, Text)
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4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w648, <w648>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A8, <w64A8>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B8, <w64B8>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
 Check all that apply
(w64C8, <w64C8>)
(String, MultiCheckbox)
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN8, <w64CN8>)
(Integer, Text)
If Other, please specify:
(w64Co8, <w64Co8>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(dd-MMM-yyyy)
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(w64DDt8, <w64DDt8>)
(Date, Text)
.
(w64D8, <w64D8>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E8, <w64E8>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo8, <w64Eo8>)
(String, Text)
3. On what date did you next take ella? (work to a date /
prompt with date of enrollment/purchase / number of days
after purchase, etc)
 Enter date:_____________ (MM/DD/YYYY)
(w63Dt9, <w63Dt9>)
(Date, Text)
(dd-MMM-yyyy)
3a. How many tablets did you take on that date?
  tablets
(w63T9, <w63T9>)
(Integer, Text)
.
(w63TA9, <w63TA9>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember  (1)
Other: (2)
If Other, please specify:
(w63TAo9, <w63TAo9>)
(String, Text)
3b. On what date did you have unprotected sex? I’m
asking about the unprotected sex that led you to take this
dose of the study drug ella.
 (work to a date / prompt with date of enrollment/purchase /
number of days after purchase, etc)
(dd-MMM-yyyy)
07-Feb-2018
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 Enter date:  (MM/DD/YYY)
(w63U9, <w63U9>)
(Date, Text)
.
(w63UA9, <w63UA9>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
3b-1. If Q3b=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w63UA19, <w63UA19>)
(String, MultiLineText)
3c. Did you take the tablet with food?
(w63C9, <w63C9>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w63Co9, <w63Co9>)
(String, Text)
4. Were you taking a daily birth control pill, or using a birth
control patch or vaginal ring at the time you took this dose
of ella?
(w649, <w649>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
 4a. If Q4=Yes: Which of those birth control methods were
you using?
 Do not read responses
 Check all that apply
(w64A9, <w64A9>)
(String, MultiCheckbox)
Birth control pill  (1)
Patch  (2)
Vaginal ring  (3)
Don’t know / Not sure / Don’t remember (4)
 4b. If Q4a Box 1, 2 or 3 checked: Were you using that
birth control method on any of the days in the week before
you took this dose of ella?
(w64B9, <w64B9>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
4c. If Q4b=Yes: If you were using that birth control method
at the time, why did you decide to take this dose of ella?
 Do not read responses
I wasn’t using my method reliably  (1)
I missed pills   (2)
Was using pills/patch/ring but had intercourse that
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 Check all that apply
(w64C9, <w64C9>)
(String, MultiCheckbox)
worried me (for example:  usually also use a condom, but it
broke)  (3)
I took it as an extra precaution / to be 100% sure I didn’t
get pregnant  (4)
Other (specify):  (5)
Don’t know / not sure / Don’t remember (6)
How many were missed during the week before taking
ella?
(w64CN9, <w64CN9>)
(Integer, Text)
If Other, please specify:
(w64Co9, <w64Co9>)
(String, Text)
4d. If Q4a Box 1, 2 or 3 checked: To the best of your
recollection, when did you start using that birth control
method (again) after you took ella?
 Enter date, encourage best estimate if uncertain.  If never
stopped, date is same as study product use
Enter date:    (MM/DD/YYYY)
(w64DDt9, <w64DDt9>)
(Date, Text)
(dd-MMM-yyyy)
.
(w64D9, <w64D9>)
(Integer, RadioCheckbox)
Did not restart that method  (1)
Don’t know / Not sure / Don’t remember (2)
4e. If Q4dDid not restart that method: Can you please tell
me HOW you restarted your pill, patch or vaginal ring?
Probe if needed: Did you start with a new pill pack, patch
or vaginal ring?
 Do not read responses
 Check all that apply
(w64E9, <w64E9>)
(String, MultiCheckbox)
I used a new pack/patch/ring  (1)
I picked up in the pack where I left off  (2)
Never stopped using HBC  (3)
Other (specify):  (4)
Don’t know / Not sure / Don’t remember (5)
If Other, please specify:
(w64Eo9, <w64Eo9>)
(String, Text)
5. Since you enrolled in the study on (date of enrollment),
have you taken any other form of emergency
contraception, other than the ella you purchased as part of
Yes  (1)
No (2)
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this study?
(w65, <w65>)
(Integer, RadioCheckbox)
5a. If Q5=Yes: What other kind of emergency
contraception did you take?
 Do not read responses
 Check all that apply
(w65A, <w65A>)
(String, MultiCheckbox)
prescription ulipristal acetate (ella), not the study drug
(1)
levonorgestrel (Plan B, My Way, Next Choice)   (2)
Other: (3)
If Other, please specify:
(w65Ao, <w65Ao>)
(String, Text)
5b. If Q5a=prescription ulipristal acetate (ella), not the
study drug: How many times did you take ella or ulipristal
acetate that you got from somewhere other than this
study? Times
(w65BN, <w65BN>)
(Integer, Text)
.
(w65B, <w65B>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w65Bo, <w65Bo>)
(String, Text)
5c. If Q5a=prescription ulipristal acetate (ella), not the
study drug:  On what date did you first take ella that you
got from somewhere other than this study?
 Enter date:_____________ (MM/DD/YYYY)
(w65C1, <w65C1>)
(Date, Text)
(dd-MMM-yyyy)
.
(w65C1dk, <w65C1dk>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember (1)
5d. How many ella tablets did you take on that date?
tablets
(w65DN1, <w65DN1>)
(Integer, Text)
.
Don’t know / Not sure /Don’t remember  (1)
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(w65D1, <w65D1>)
(Integer, RadioCheckbox)
Other: (2)
If Other, please specify:
(w65Do1, <w65Do1>)
(String, Text)
5c. If Q5a Box 1 checked: On what date did you next take
ella that you got from somewhere other than this study?
 Enter date:_____________ (MM/DD/YYYY)
(w65C2, <w65C2>)
(Date, Text)
(dd-MMM-yyyy)
5d. How many ella tablets did you take on that date?
tablets
(w65DN2, <w65DN2>)
(Integer, Text)
.
(w65D2, <w65D2>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w65Do2, <w65Do2>)
(String, Text)
5c. If Q5a Box 1 checked: On what date did you next take
ella that you got from somewhere other than this study?
 Enter date:_____________ (MM/DD/YYYY)
(w65C3, <w65C3>)
(Date, Text)
(dd-MMM-yyyy)
5d. How many ella tablets did you take on that date?
tablets
(w65DN3, <w65DN3>)
(Integer, Text)
.
(w65D3, <w65D3>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w65Do3, <w65Do3>)
(String, Text)
6. If Q5=Yes AND Q5a =levonogestrel or other: How many
times have you taken any other form of emergency
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contraception not including ella, either from this study or
another source, since (date of enrollment).
  Times
(w66N, <w66N>)
(Integer, Text)
.
(w66, <w66>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w66O, <w66O>)
(String, Text)
Tab Total from week 2 interview:
(w67tabC, <w67tabC>)
(String, PlainText)
If Q1 from Week 2 = Yes AND (number of tablets
purchased – number of tablets previously reported to have
been taken ≥ 1):
 7. When we spoke approximately 4 weeks ago, you said
that you had taken (number of tablets previously reported
to have been taken) doses of ella.  Have you taken any
additional tablets of ella that you purchased as part of this
study at any time since we last spoke on (date of week 2
interview)?
(w67, <w67>)
(Integer, RadioCheckbox)
Yes  (1)
No  (Skip to Q8) (2)
7a.  If Q7=Yes: Do you remember the date you took the
study drug ella after our last interview?
  Enter date :   (MM/DD/YYYY)
(w67A, <w67A>)
(Date, Text)
(dd-MMM-yyyy)
.
(w67Ano, <w67Ano>)
(Integer, RadioCheckbox)
No (1)
7b. If Q7a=No: If you don’t recall a specific date, what can
you tell me about WHEN you took the study drug ella after
our last interview?
 Record verbatim response, e.g. “I took it about a week
after the last interview”, “I took it a few days ago”, “I don’t
remember”.
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(w67B, <w67B>)
(String, MultiLineText)
7c. How many ella tablets did you take on that date?
tablets
(w67Cn, <w67Cn>)
(Integer, Text)
.
(w67C, <w67C>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w67Co, <w67Co>)
(String, Text)
7d. How many days after you had unprotected sex did you
use ella?
 Enter date:_____________ (MM/DD/YYYY)
(w67D, <w67D>)
(Date, Text)
(dd-MMM-yyyy)
.
(w67Dno, <w67Dno>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
7d-1. If Q7d=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w67D1, <w67D1>)
(String, MultiLineText)
7e. Do you remember if you took the tablet with food?
(w67E, <w67E>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w67Eo, <w67Eo>)
(String, Text)
7a.  If Q7=Yes: Do you remember the date you took the
study drug ella after our last interview?
  Enter date :   (MM/DD/YYYY)
(w67A2, <w67A2>)
(Date, Text)
(dd-MMM-yyyy)
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.
(w67Ano2, <w67Ano2>)
(Integer, RadioCheckbox)
No (1)
7b. If Q7a=No: If you don’t recall a specific date, what can
you tell me about WHEN you took the study drug ella after
our last interview?
 Record verbatim response, e.g. “I took it about a week
after the last interview”, “I took it a few days ago”, “I don’t
remember”.
(w67B2, <w67B2>)
(String, MultiLineText)
7c. How many ella tablets did you take on that date?
tablets
(w67Cn2, <w67Cn2>)
(Integer, Text)
.
(w67C2, <w67C2>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w67Co2, <w67Co2>)
(String, Text)
7d. How many days after you had unprotected sex did you
use ella?
 Enter date:_____________ (MM/DD/YYYY)
(w67D2, <w67D2>)
(Date, Text)
(dd-MMM-yyyy)
.
(w67Dno2, <w67Dno2>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
7d-1. If Q7d=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
(w67D12, <w67D12>)
(String, MultiLineText)
7e. Do you remember if you took the tablet with food?
(w67E2, <w67E2>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
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(w67Eo2, <w67Eo2>)
(String, Text)
7a.  If Q7=Yes: Do you remember the date you took the
study drug ella after our last interview?
  Enter date :   (MM/DD/YYYY)
(w67A3, <w67A3>)
(Date, Text)
(dd-MMM-yyyy)
.
(w67Ano3, <w67Ano3>)
(Integer, RadioCheckbox)
No (1)
7b. If Q7a=No: If you don’t recall a specific date, what can
you tell me about WHEN you took the study drug ella after
our last interview?
 Record verbatim response, e.g. “I took it about a week
after the last interview”, “I took it a few days ago”, “I don’t
remember”.
(w67B3, <w67B3>)
(String, MultiLineText)
7c. How many ella tablets did you take on that date?
tablets
(w67Cn3, <w67Cn3>)
(Integer, Text)
.
(w67C3, <w67C3>)
(Integer, RadioCheckbox)
Don’t know / Not sure /Don’t remember  (1)
Other: (2)
If Other, please specify:
(w67Co3, <w67Co3>)
(String, Text)
7d. How many days after you had unprotected sex did you
use ella?
 Enter date:_____________ (MM/DD/YYYY)
(w67D3, <w67D3>)
(Date, Text)
(dd-MMM-yyyy)
.
(w67Dno3, <w67Dno3>)
(Integer, RadioCheckbox)
Did not have unprotected sex (1)
7d-1. If Q7d=‘Did not have unprotected sex’: If you did not
have unprotected sex, why did you use ella?
 Enter verbatim response:
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(w67D13, <w67D13>)
(String, MultiLineText)
7e. Do you remember if you took the tablet with food?
(w67E3, <w67E3>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember  (3)
Other: (4)
If Other, please specify:
(w67Eo3, <w67Eo3>)
(String, Text)
If Q7 Week 2=No or Week 2 interview not conducted:
 8. Since you enrolled in the study on (date of enrollment),
have you had a menstrual period?
(w68, <w68>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
8a.  If Q8=Yes: To the best of your recollection, what day
did that menstrual period start?
 Enter date, encourage best estimate if uncertain
  (MM/DD/YYYY)
(w68A, <w68A>)
(Date, Text)
(dd-MMM-yyyy)
.
(w68dk, <w68dk>)
(Integer, RadioCheckbox)
Don’t know / Not sure / Don’t remember (1)
Read: The next few questions I’ll ask about sexual
intercourse.  When I ask about sexual intercourse, I am
talking about heterosexual vaginal sex (not oral sex or
same-gender partner sex).
  If Q1=Yes or Q8=Yes AND (Week 2 Q8) not asked:
 9. Between when you took the first dose of ella from this
study and (Q8=Yes (date of last period) OR Q8=No
(today’s date)), did you have sexual intercourse?
(w69, <w69>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
9a.  If Q9=Yes: Did you use anything or take anything to
prevent pregnancy when you had sex during that time
(after you first took the study drug ella and (before your
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
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period started) or (now))?
(w69A, <w69A>)
(Integer, RadioCheckbox)
9b.  If Q9a=Yes: What are all the birth control methods you
were using to prevent pregnancy when you had sex during
that time (after you first took the study drug ella and
(before your period started) or (now))?
 Do not read responses
 Check all that apply
(w69B, <w69B>)
(String, MultiCheckbox)
Condoms  (01)
Diaphragm  (02)
Sponge  (03)
Spermicide  (04)
Birth control pills/patch/vaginal ring  (05)
Long-acting contraceptives (implant/injection/IUD)  (06)
Partner wasn’t male  (07)
Didn’t have vaginal intercourse  (08)
Withdrawal  (09)
Natural family planning/rhythm method  (10)
Don’t know / Not sure / Don’t remember  (11)
Other (specify): (12)
If Other, please specify:
(w69Bo, <w69Bo>)
(String, Text)
9c.  If ((Q9=Yes AND Q9a=No) OR (Q9b Condoms or
Diaphragm or Sponge)): Have you used a condom or other
barrier method of birth control (like a sponge or diaphragm)
during intercourse since you first used ella from this study?
(w69C, <w69C>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
9d.  If (Q9b=Condoms or Diaphragm or Sponge) OR
Q9c=Yes: How often did you use (a
condom/diaphragm/sponge) when you had sex after first
using ella and (before your menstrual period started) or
(now)?
(w69D, <w69D>)
(Integer, RadioCheckbox)
Every time  (1)
Most of the time (more than 50% of the time)  (2)
Some of the time (less than 50% of the time) (3)
The next question is about unprotected sex. The next few
questions ask about unprotected sex.  When I ask about
unprotected sex, I am talking about heterosexual vaginal
sexual intercourse that could lead to pregnancy.  This
includes sex where you did not use any birth control or sex
where your contraception failed (for example, your partner
did not use a condom or a condom broke during sex).
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
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   10.  If Q9=Yes: Have you had unprotected sex since
enrolling in the study?
(w610, <w610>)
(Integer, RadioCheckbox)
Adverse Event Trigger Questions
 These questions should be asked of everybody to determine if any adverse events need to be recorded.
 Now I’m going to ask you some questions about any other health problems you may have had during the
study.
  Since you enrolled in the ella study, have you been to the doctor for any reason not already discussed?
 Since you enrolled in the ella study, have you developed any new medical problems not already discussed?
 Since you enrolled in the ella study, have you been to a hospital as a patient for any reason?
  Also consider new medications or changes in medications reported.
 Based on the responses to all questions go to the Adverse Events Form and complete as necessary.
Complete Concomitant Medication Form and Continue to
End of Study Interview
 11. Since you enrolled in this study on (date of
enrollment), have you started taking any new medications?
(w611, <w611>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
.
(w6NC, <w6NC>)
(Integer, RadioCheckbox)
Not contacted  (1)
Refused Interview (2)
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22 END-OF-STUDY OR EARLY TERMINATION INTERVIEW
(eos, <eos>)
22 END-OF-STUDY OR EARLY TERMINATION INTERVIEW
 I would now like to continue and ask you some end-of-study questions we are asking of all participants in
our study.
Subject Number:
(eSub, <eSub>)
(String, Text)
Date of interview:
(eDT, <eDT>)
(Date, Text)
(dd-MMM-yyyy)
If (Week 2 Q1=Yes OR Week 6 Q1=Yes):
 1. During the study, did you ever vomit within 3 hours of
taking ella?
(e1, <e1>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
1a. If Q1=Yes: Did you do anything in particular because
you vomited within 3 hours of taking ella?
 Do not read responses
 Check all that apply
(e1a, <e1a>)
(String, MultiCheckbox)
Talked to a healthcare professional   (1)
Took another tablet of ella  (2)
Took another form of emergency contraception  (3)
Did nothing  (4)
Other: (5)
When?
(e1aW, <e1aW>)
(Date, Text)
(dd-MMM-yyyy)
If Other, please specify:
(e1aO, <e1aO>)
(String, Text)
1b. If Q1=Yes AND Q1a Talked to a healthcare
professional: Did you call a healthcare professional to find
out if you should repeat the dose?
(e1b, <e1b>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
Why not?
(e1bW, <e1bW>)
(String, Text)
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1c. If Q1=Yes AND (Q1a=Talked to a healthcare
professional OR Q1b=Yes): When you talked to your
healthcare professional, did you tell him or her that you
had taken ella and had vomited afterward?
(e1c, <e1c>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
1d.  If Q1=Yes AND (Q1a=Talked to a healthcare
professional OR Q1b=Yes):  What did your healthcare
professional tell you?
(e1d, <e1d>)
(String, MultiLineText)
If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (EOS
Q1b=NO OR AE Q1b does not contain ‘Talked to a
healthcare professional’ )
 2. The instructions on the package say to call a healthcare
professional to find out if you should repeat the dose if you
vomit within 3 hours of taking ella.  You told us that you
vomited within 3 hours after taking ella.  Why did you
decide not to call a healthcare professional to find out if
you should repeat the dose?   Record verbatim response
(e2, <e2>)
(String, MultiLineText)
3. Did you ever breastfeed around the time you took the
ella from this study?
(e3, <e3>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
3a. If Q3=Yes: The instructions on the package say not to
take ella if you are breastfeeding.  Why did you decide to
take ella even though you were breastfeeding? Record
verbatim response
(e3a, <e3a>)
(String, MultiLineText)
 If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (Week 2
Q3b date-Q3 date is >5 days OR Week 6 Q3b date-Q3
date is >5 days OR Week 6 Q7d date-Q7a date >5 days):
 4. The instructions on the package say to take ella as
soon as possible and no later than 5 days after
unprotected sex.  You told us that you took ella more than
5 days after unprotected sex.  Why did you decide to take
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ella even though it was more than 5 days after unprotected
sex?    Record verbatim response
(e4, <e4>)
(String, MultiLineText)
 If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND ((Week 2
Q4b=Yes AND Q4d date-Q3 date<5 days) OR (Week 6
Q4b=Yes AND Q4d date-Q3 date<5 days)):
 5. The instructions on the package say not to use birth
control pills, patch, or ring for 5 days after taking ella.  You
told us that you started using birth control pills, patch or
ring sooner than 5 days after taking ella.  Why did you
decide to start using birth control pills/patches/rings sooner
than 5 days after taking ella?    Record verbatim response
(e5, <e5>)
(String, MultiLineText)
 If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (Week 2
Q4e not contains box 1 OR Week 6 Q4e not contains box
1):
 6. The instructions on the package insert say to restart
with a new pack of pills (or a new patch or vaginal ring).
Why did you decide not to follow this instruction?    Record
verbatim response
(e6, <e6>)
(String, MultiLineText)
 If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (Week 2
Q4d= ‘Date’ OR ‘Don’t know / Not sure / Don’t remember’
OR Week 6 Q4d=‘Date’ OR ‘Don’t know / Not sure / Don’t
remember’) AND (((Week 2 (Q8b Condoms or Diaphragm
or Sponge) OR Q8c=No) OR (Week 6 (Q9b Condoms or
Diaphragm or Sponge) OR Q9c=No))):
 7. The instructions on the package say to use condoms
(or another barrier method, a sponge or diaphragm for
example) every time you have sex from the time you take
ella until the start of your next menstrual period, even if
you start or restart birth control pills, patches, or rings.
Why did you not use condoms or another barrier method
every time you had sex until your next menstrual period?
Record verbatim response
(e7, <e7>)
(String, MultiLineText)
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 If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (Week 2
Q4 = No OR Q4d= ‘Did not restart that method’ OR Week
6 Q4 = No OR Q4d=‘Did not restart that method’ ) AND
(((Week 2 (Q8b Condoms or Diaphragm or Sponge) OR
Q8c=No) OR (Week 6 (Q9b Condoms or Diaphragm or
Sponge) OR Q9c=No))):
 8. The instructions on the package say to use condoms
(or another barrier method) every time you have sex from
the time you take ella until the start of your next menstrual
period.  Why did you not use condoms or another barrier
method every time you had sex until your next menstrual
period?    Record verbatim response
(e8, <e8>)
(String, MultiLineText)
 If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (Week 2
Q3a is >1 OR Week 6 Q3a is >1):
 9. The instructions on the package say not to take more
than one tablet of ella at a time.  Why did you decide to
take more than one tablet of ella at one time?     Record
verbatim response
(e9, <e9>)
(String, MultiLineText)
 If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (any sum
of number of tablets >1 reported in Week 2 (Q3a AND
Q5d) AND Week 6 (Q3a AND Q5d AND Q7c ):
 10. You reported taking ella on more than two occasions
during the course of the study.  Did you have a menstrual
cycle between each dose?
(e10, <e10>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
10a. If Q10 = No or Don’t know / Not sure / Don’t
remember: The instructions on the package say not to take
more than one dose of ella in the same menstrual cycle.
Why did you decide to take ella more than once within a
single menstrual cycle? Record verbatim response
(e10a, <e10a>)
(String, MultiLineText)
If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (ConMed
table box 7 not checked):
Yes  (1)
No  (2)
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 11. Did you talk to a healthcare professional or pharmacist
about the medicines you take before you took ella?
(e11, <e11>)
(Integer, RadioCheckbox)
Don’t know / Not sure (3)
reported ask a doctor or pharmacist drugs:
Subject reported taking barbiturates, carbamazepine,
felbamate, oxcarbazepine, phenytoin, or topiramate
(cmMed1, <cmMed1>)
(String, PlainText)
Subject reported taking rifampin
(cmMed2, <cmMed2>)
(String, PlainText)
Subject reported taking griseofulvin
(cmMed3, <cmMed3>)
(String, PlainText)
Subject reported taking bosentan
(cmMed4, <cmMed4>)
(String, PlainText)
Subject reported taking St. John’s Wort or any herbal
product containing hypericum perforatum
(cmMed5, <cmMed5>)
(String, PlainText)
Subject reported taking medicine to treat HIV/AIDS
(cmMed6, <cmMed6>)
(String, PlainText)
11a. If Q11=No: The instructions inside the package tell
you to talk to a healthcare professional or a pharmacist
before you take ella if you are taking (reported ask a doctor
or pharmacist drug).  Why didn’t you do that?
(e11a, <e11a>)
(String, MultiLineText)
.
(e11aR, <e11aR>)
(Integer, RadioCheckbox)
Reported starting this medication AFTER use of ella. (1)
12. As far as you know, are you pregnant?
(e12, <e12>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure (3)
If (Week 2 Q1=Yes OR Week 6 Q1=Yes) AND (Week 2
Yes  (1)
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Q7 box 1 NOT checked AND Week 6 Q8 box 1 NOT
checked) AND EOS Q12=No:
 13. The instructions on the package say to do a
pregnancy test if you are more than one week late getting
your period.  You told us that you haven’t had a period
since you enrolled in this study on (date of enrollment).
Did you take any pregnancy test when your period was
late?
(e13, <e13>)
(Integer, RadioCheckbox)
No (2)
Why did you not take a pregnancy test? Record verbatim
response
(e13a, <e13a>)
(String, MultiLineText)
If (Week 2 Q1=Yes OR Week 6 Q1=Yes)
 14. At any time since you took ella have you had severe
lower abdominal pain?
(e14, <e14>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
14a. If Q14=Yes:  Did you do anything in particular when
you had lower abdominal pain any time after taking ella?
 Check all that apply
(e14a, <e14a>)
(String, MultiCheckbox)
Talked to a healthcare professional   (1)
Stopped taking ella  (2)
Did nothing  (3)
Other: (4)
When?
(e14aW, <e14aW>)
(Date, Text)
(dd-MMM-yyyy)
If Other, please specify:
(e14aO, <e14aO>)
(String, Text)
14b. If Q14=Yes AND Q14a Talked to a healthcare
professional: Did you contact a healthcare professional
about it?
(e14b, <e14b>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Why not?
(e14ba, <e14ba>)
(String, MultiLineText)
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14c. If Q14=Yes AND (Q14a=Talked to a healthcare
professional OR Q14b=Yes): When you talked to your
healthcare professional, did you tell him or her that you
had taken ella?
(e14c, <e14c>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
14d. If Q14=Yes AND (Q14a=Talked to a healthcare
professional OR Q14b=Yes):  What did your healthcare
professional tell you?
(e14d, <e14d>)
(String, MultiLineText)
Complete End of Study Pregnancy Test Results form.
  Read: That concludes this interview and your
participation in the study. Your compensation for this
interview will come to you (in the mail in the next 2 weeks)
(or) (via email in the next few days).  Please use the pre-
addressed and stamped envelope provided to you when
you enrolled to return ALL unused study medication or any
empty medicine packaging.  Thank you for your time today
and for participating in our study.  If you need any
emergency contraception in the future, you can purchase
over-the-counter options or talk to a healthcare provider.
  If subject indicates that empty medication packaging was
thrown away and none will be returned, check box:
(eNonRtrn, <eNonRtrn>)
(Integer, RadioCheckbox)
All empty packaging reported disposed of by subject,
none to return. (1)
.
(eNC, <eNC>)
(Integer, RadioCheckbox)
Not contacted  (1)
Refused Interview (2)
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23 END OF STUDY PREGNANCY TEST RESULTS
(epreg, <epreg>)
23 END OF STUDY PREGNANCY TEST RESULTS
1. Have you taken the pregnancy test provided to you
when you enrolled in this study?
(ep1, <ep1>)
(Integer, RadioCheckbox)
Yes  (1)
No Read: Do you have the test that you could take now
while I wait? If not able to take test now or needs another
test provided:        Read: We will send you another test.
Please take it when you receive it and call us back with the
results.
 Confirm mailing address.  (2)
Don’t know / Not sure / Don’t remember  (3)
Refused (4)
1a. If Q1=Yes: To the best of your recollection, do you
remember the date you took the pregnancy test?
(ep1a, <ep1a>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
I don’t remember   (3)
Other (4)
Enter date:
(ep1aDT, <ep1aDT>)
(Date, Text)
(dd-MMM-yyyy)
If Other, please specify:
(ep1aO, <ep1aO>)
(String, Text)
1b. If Q1aYes: If you don’t recall a specific date, what can
you tell me about WHEN you took the pregnancy test?
  days ago
(ep1bD, <ep1bD>)
(Integer, Text)
weeks ago
(ep1bW, <ep1bW>)
(Integer, Text)
.
(ep1b, <ep1b>)
(Integer, RadioCheckbox)
Don’t remember  (1)
Other: (2)
If Other, please specify:
(ep1bO, <ep1bO>)
(String, Text)
1c. If Q1=Yes: What was the result of the pregnancy test?
Positive - Complete EIU form  (1)
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(ep1c, <ep1c>)
(Integer, RadioCheckbox)
Negative  (2)
Test malfunctioned or results unclear. Read: We will
send you another test. Please take it when you receive it
and call us back with the results.  Confirm mailing address.
(3)
Don’t know / Not sure / Don’t remember Read: We will
send you another test. Please take it when you receive it
and call us back with the results.  Confirm mailing address.
(4)
1d. If Q1c=Yes: Have you contacted a healthcare provider
to confirm your pregnancy?
(ep1d, <ep1d>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Why not?
(ep1dW, <ep1dW>)
(String, MultiLineText)
1e. If Q1d=Yes: When you talked to your healthcare
professional, did you tell him or her that you had taken
ella?
(ep1e, <ep1e>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
1f. If Q1e=Yes: What did your healthcare professional tell
you? Record verbatim response
(ep1f, <ep1f>)
(String, MultiLineText)
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Sub Forms
[24 AE / SAE / EIU FORMS]
 
24 AE / SAE / EIU FORMS
(aesum, <aesum>)
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24 AE / SAE / EIU FORMS
(ae, <ae>)
24 AE / SAE / EIU FORMS
Follow up questions not to be asked directly to the subject,
unless prompted:
1. Did the subject spontaneously report any vomiting after
taking study drug ella?
(ae1, <ae1>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
1a. If Q1=Yes: Was it within 3 hours of taking study drug
ella?
(ae1A, <ae1A>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know / Not sure / Don’t remember (3)
If Q1 = Yes: When is this AE being collected?
If ‘During the EOS interview” skip to Q2
(ae1A2, <ae1A2>)
(String, MultiCheckbox)
During the Week 2 Interview  (1)
During the Week 6 Interview  (2)
During the EOS interview  (3)
Spontaneously reported (4)
1b. You mentioned you vomited within 3 hours of taking
ella from this study.  Afterward, did you do anything in
particular because you vomited within 3 hours of taking
ella?
Do not read responses
 Check all that apply
(ae1B1, <ae1B1>)
(Integer, RadioCheckbox)
Talked to a healthcare professional: (1)
.
(ae1B, <ae1B>)
(String, MultiCheckbox)
Took another ella tablet  (2)
Took another form of emergency contraception  (3)
Did nothing  (4)
Other: (5)
When?
(ae1Bw, <ae1Bw>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Other, please specify:
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(ae1Bo, <ae1Bo>)
(String, Text)
1c. If Q1b=Talked to a healthcare professional:  When you
talked to your healthcare professional, did you tell him or
her that you had taken ella and had vomited afterward?
(ae1C, <ae1C>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
1d. If Q1c=Yes  What did your healthcare professional tell
you?
(ae1D, <ae1D>)
(String, MultiLineText)
2. Did the subject spontaneously report severe lower
abdominal pain any time during the study after taking study
drug ella?
(ae2, <ae2>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
If Q2 = Yes: When is this AE being collected?
If ‘During the EOS interview” skip to Adverse Event Term
(ae2_2, <ae2_2>)
(String, MultiCheckbox)
During the Week 2 Interview  (1)
During the Week 6 Interview  (2)
During the EOS interview  (3)
Spontaneously reported (4)
2a. You mentioned you had severe lower abdominal pain
after taking ella from this study. What, if anything, did you
do about that?
Do not read responses
 Check all that apply
(ae2A, <ae2A>)
(String, MultiCheckbox)
Talked to a healthcare professional:   (1)
Did nothing  (2)
Other: (3)
When?
(ae2Aw, <ae2Aw>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
If Other, please specify:
(ae2Ao, <ae2Ao>)
(String, Text)
 2b. If Q2a=Talked to a healthcare professional:  When you
Yes  (1)
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talked to your healthcare professional, did you tell him or
her that you had taken ella?
(ae2B, <ae2B>)
(Integer, RadioCheckbox)
No (2)
2c. If Q2b=Yes  What did your healthcare professional tell
you or do for you?  What did they say was causing your
pain?
(ae2C, <ae2C>)
(String, MultiLineText)
Serious Adverse Event Report Form
Diagnosis/syndrome of AE:
(ae_evnt, <ae_evnt>)
(String, Text)
Is the event serious?
(aeSRS, <aeSRS>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
Study No:
(stNo, <stNo>)
(String, Text)
Investigator’s Name
(Iname, <Iname>)
(String, Text)
Centre No:
(CenNo, <CenNo>)
(String, Text)
Patient No.
(PatNo, <PatNo>)
(String, Text)
Treatment / Randomization No.
(TreRN, <TreRN>)
(String, Text)
Country
(Cntry, <Cntry>)
(String, Text)
Patient information
Patient Initials:
  first
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(piF, <piF>)
(String, Text)
mid
(piM, <piM>)
(String, Text)
last
(piL, <piL>)
(String, Text)
Date of Birth:
  day month year
(aeDOB, <aeDOB>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Age:
(aeAge, <aeAge>)
(String, Text)
Sex:
(aeSex, <aeSex>)
(Integer, RadioCheckbox)
male  (1)
female (2)
Height (in):
(aeht, <aeht>)
(String, Text)
Weight (lbs):
(aewt, <aewt>)
(String, Text)
Adverse event information
Report type:
 *For follow-up report, give only changes to previous
 Onset of first signs/symptoms of SAE:
(aeRpTp, <aeRpTp>)
(Integer, RadioCheckbox)
initial  (1)
follow up* (2)
day / month / year
(ae_st_dt, <ae_st_dt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Time since last dose of study medication:
 (days) /
(ae_lsDa, <ae_lsDa>)
(String, Text)
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(hours) /
(ae_lsHr, <ae_lsHr>)
(String, Text)
(minutes)
(ae_lsMn, <ae_lsMn>)
(String, Text)
or
(ae_ls_na, <ae_ls_na>)
(Integer, RadioCheckbox)
NA (1)
Seriousness criteria (tick all that apply).
 IF the event was serious or a protocol specified significant
AE, please complete an SAE form
(ae_ser, <ae_ser>)
(String, MultiCheckbox)
Death  (1)
Life Threatening  (2)
Hospitalization (required or prolonged)  (3)
Persistent or significant disability / in capacity  (4)
Congenital anomaly / birth defect  (5)
Medically important event (6)
.  day / month / year
(ae_serD, <ae_serD>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Did the patient take a significant overdose?
(oDose, <oDose>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
Is the event due to lack of efficacy?
(lEff, <lEff>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
Description of adverse event
Description:
(ae_desc, <ae_desc>)
(String, MultiLineText)
Description(Cont.)
(ae_desc2, <ae_desc2>)
(String, MultiLineText)
Component signs or symptoms (only if applicable)
 1.
(aeComp1, <aeComp1>)
(String, Text)
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2.
(aeComp2, <aeComp2>)
(String, Text)
3.
(aeComp3, <aeComp3>)
(String, Text)
4.
(aeComp4, <aeComp4>)
(String, Text)
5.
(aeComp5, <aeComp5>)
(String, Text)
6.
(aeComp6, <aeComp6>)
(String, Text)
Study medication:
 Date started  day / month / year
(smStDt, <smStDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Date ended day / month / year
(smSpDt, <smSpDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Drug code broken:
(dcBrok, <dcBrok>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
if yes result:
(dcBrokR, <dcBrokR>)
(String, Text)
Trial indication:
(trlInd, <trlInd>)
(String, MultiLineText)
Daily dose:
(dDos, <dDos>)
(String, Text)
Route of administration:
(Rt, <Rt>)
(String, Text)
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Batch No.:
(BtchNo, <BtchNo>)
(String, Text)
Intensity of Event
(aeInt, <aeInt>)
(Integer, RadioCheckbox)
Mild  (1)
Moderate  (2)
Severe (3)
Action Taken
Study medication :
(acMed, <acMed>)
(Integer, RadioCheckbox)
No change in study medication  (1)
Dosage increased due to event  (2)
Dosage decreased due to event  (3)
Discontinued and reintroduced, no event recurred  (4)
Discontinued and reintroduced, same event recurred  (5)
Discontinued due to event (6)
Other measures than action on study medication?
(acOms, <acOms>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
If YES,
Medication :
(acOmsY, <acOmsY>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
(please specify):
(acOmsYS, <acOmsYS>)
(String, Text)
Other (please specify):
(acOmsYO, <acOmsYO>)
(String, Text)
Outcome of patient / SAE
(OtCome, <OtCome>)
(Integer, RadioCheckbox)
Recovery without sequelae on:  (1)
Recovering/resolving  (2)
Ongoing at time of this report  (3)
Recovery with sequelae:  (4)
Subject died (5)
. day / month / year
(RwoSq, <RwoSq>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
. day / month / year
(RwSq, <RwSq>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
•Autopsy performed?
No  (1)
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(autop, <autop>)
(Integer, RadioCheckbox)
Yes (if YES, please provide a copy of the autopsy
report)  (2)
Planned (3)
•Death due to SAE?
(dDueAE, <dDueAE>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
if No, cause of death:
(csDth, <csDth>)
(String, Text)
Assessment of causality
In the investigator’s opinion the relationship between the
reported adverse event(s) and the study medication is:
(aeCas, <aeCas>)
(Integer, RadioCheckbox)
Certain  (1)
Possible  (2)
Unlikely  (3)
Not related (4)
If unlikely or not related, in the investigator’s opinion, the
reported adverse event is:
(aeRel, <aeRel>)
(Integer, RadioCheckbox)
related to study procedures  (1)
unrelated to study procedures (2)
Relevant medical history
 (e.g. previous diseases, surgery, allergies, pregnancy)
(relMH, <relMH>)
(String, MultiLineText)
Tests / laboratory findings
 (relevant for SAE diagnosis or course description)
 Test/lab name
(tname1, <tname1>)
(String, Text)
Date
 day / month / year
(tDt1, <tDt1>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Unit
(tUnit1, <tUnit1>)
(String, Text)
Result / value
(tReslt1, <tReslt1>)
(String, Text)
Test/lab name
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(tname2, <tname2>)
(String, Text)
Date
 day / month / year
(tDt2, <tDt2>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Unit
(tUnit2, <tUnit2>)
(String, Text)
Result / value
(tReslt2, <tReslt2>)
(String, Text)
Test/lab name
(tname3, <tname3>)
(String, Text)
Date
 day / month / year
(tDt3, <tDt3>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Unit
(tUnit3, <tUnit3>)
(String, Text)
Result / value
(tReslt3, <tReslt3>)
(String, Text)
Test/lab name
(tname4, <tname4>)
(String, Text)
Date
 day / month / year
(tDt4, <tDt4>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Unit
(tUnit4, <tUnit4>)
(String, Text)
Result / value
(tReslt4, <tReslt4>)
(String, Text)
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Test/lab name
(tname5, <tname5>)
(String, Text)
Date
 day / month / year
(tDt5, <tDt5>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Unit
(tUnit5, <tUnit5>)
(String, Text)
Result / value
(tReslt5, <tReslt5>)
(String, Text)
Investigator’s Signature
Name:
(iName, <iName>)
(String, Text)
Address:
(iAddrs, <iAddrs>)
(String, Text)
Date of this report:    day / month / year
(rptDT, <rptDT>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
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Pregnancy Collection Form (emergency contraception)
(pr, <pr>)
Pregnancy Collection Form
 (emergency contraception)
 page : 1 of 6
 Please return this form to HRA Pharma Pharmacovigilance 15 rue Beranger 75003 PARIS,
 fax : 01.42.77.03.52, e-mail : pharmacovigilance@hra-pharma.com
For internal use only: Reception date of the information
(D0)
(prRdt, <prRdt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Case No:HRA-
(prCsNo1, <prCsNo1>)
(String, Text)
REPORTER INFORMATION
Last name :
(prLn, <prLn>)
(String, Text)
First name :
(prFn, <prFn>)
(String, Text)
Address :
(prAd, <prAd>)
(String, Text)
Phone:
(prPhn, <prPhn>)
(String, Text)
Fax :
(prFax, <prFax>)
(String, Text)
Date:
(prDt, <prDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Signature :
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(prSig, <prSig>)
(String, Text)
Health Care Professional
(prHCP, <prHCP>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Country:
(prCntry, <prCntry>)
(String, Text)
Email :
(prEml, <prEml>)
(String, Text)
PATIENT IDENTIFICATION
Initials :
(prIntls, <prIntls>)
(String, Text)
Height:
(prHt, <prHt>)
(String, Text)
Date of birth (DD/MM/YYYY):
(prDOB, <prDOB>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
or age:
(prAge, <prAge>)
(String, Text)
Weight:
(prWt, <prWt>)
(String, Text)
PREGNANCY INFORMATION
Date of last mentrual period :
(prLMPDt, <prLMPDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Date of pregnancy diagnosis :
(prPDdt, <prPDdt>)
(dd[UNK]-MMM[UNK]-yyyy)
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(PartialDate, PartialDate)
Pregnancy stage at time of diagnosis :
(prStage, <prStage>)
(String, Text)
Expected delivery date :
(prEDDdt, <prEDDdt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
EMERGENCY CONTRACEPTION EXPOSURE
Drug name :
(prDname, <prDname>)
(String, Text)
Total dose administered :
(prTdos, <prTdos>)
(String, Text)
Time from intercourse to drug intake (hours or days) :
(prTmint, <prTmint>)
(String, Text)
Date of intake:
(prIntkDt, <prIntkDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Batch number:
(prBtchNo, <prBtchNo>)
(String, Text)
Exp. date:
(prExpDt, <prExpDt>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Pregnancy status before emergency contraception intake :
(prPreg, <prPreg>)
(Integer, RadioCheckbox)
Not Pregnant /  (1)
Pregnant (2)
If pregnant, pregnancy stage at drug exposure (in weeks of
amenorrhea) :
(prPregst, <prPregst>)
(String, Text)
Additional intake of HRA Pharma emergency contraception
during pregnancy?
(prAdIn, <prAdIn>)
No  (1)
Yes (2)
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(Integer, RadioCheckbox)
: How many?
(prAdInH, <prAdInH>)
(String, Text)
Period of exposure:
(prPex, <prPex>)
(Integer, RadioCheckbox)
1ST TRIM.  (1)
2ND TRIM.  (2)
3RD TRIM.  (3)
UNK (4)
Use of hormonal contraception after emergency
contraception intake in the same menstrual cycle?
(prUHrm, <prUHrm>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
: Name
(prUHrmN, <prUHrmN>)
(String, Text)
Start date after emergency contraception intake:
(prUHrmD, <prUHrmD>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
PREGNANCY OUTCOME
.
(prLB, <prLB>)
(Integer, RadioCheckbox)
Live birth (1)
.
(prHChld, <prHChld>)
(Integer, RadioCheckbox)
Healthy child Thank you for completing this form.
 No further information is requested (1)
Pregnancy term (weeks)
(prPrTrm, <prPrTrm>)
(String, Text)
Number of children born
(prNoOfC, <prNoOfC>)
(String, Text)
For each child, please specify :
 Sex :
(prBsx1, <prBsx1>)
(String, Text)
Birth weight (kg) :
(prBwt1, <prBwt1>)
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(String, Text)
Sex :
(prBsx2, <prBsx2>)
(String, Text)
Birth weight (kg) :
(prBwt2, <prBwt2>)
(String, Text)
Sex :
(prBsx3, <prBsx3>)
(String, Text)
Birth weight (kg) :
(prBwt3, <prBwt3>)
(String, Text)
Thank you for completing this form.
 No further information is requested.
.
(prCong, <prCong>)
(Integer, RadioCheckbox)
Congenital anomaly  Please complete pages 2 and 4 (1)
.
(prNeoDth, <prNeoDth>)
(Integer, RadioCheckbox)
Neonatal death  Please complete pages 2 and 5 (1)
.
(prElAb, <prElAb>)
(Integer, RadioCheckbox)
Elective abortion (no medical reason) please complete
pages 2 and 3 (1)
.
(prMtDth, <prMtDth>)
(Integer, RadioCheckbox)
Maternal death   Thank you for completing this form.
You will be contacted very soon for further information. (1)
.
(prOthOt, <prOthOt>)
(Integer, RadioCheckbox)
Induced therapeutic abortion (in case of anomaly
discovered during a prenatal diagnosis)   Please complete
pages 2 and 6  (1)
Spontaneous abortion (less than 20 completed weeks of
pregnancy)   Please complete pages 2 and 6  (2)
Premature fetal death (20-27 completed weeks of
pregnancy)   Please complete pages 2 and 6  (3)
Late fetal death (≥ 28 completed weeks of pregnancy)
Please complete pages 2 and 6  (4)
Ectopic pregnancy   Please complete pages 2 and 6 (5)
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Pregnancy Collection Form
 (emergency contraception)
 page : 2 of 6
Patient ID: Initials
(prPIDint, <prPIDint>)
(String, Text)
Date of birth:
(prDOB2, <prDOB2>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
For internal use only :  Case No:HRA-
(prCsNo2, <prCsNo2>)
(String, Text)
MATERNAL HISTORY
History of pregnancy
(prHOP, <prHOP>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, how many :
(prHOPH, <prHOPH>)
(String, Text)
and number of live infants
(prHOPN, <prHOPN>)
(String, Text)
History of spontaneous abortion (miscarriage)
(prHOSA, <prHOSA>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, how many :
(prHOSAH, <prHOSAH>)
(String, Text)
History of fetal death ?
(prHOFD, <prHOFD>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, how many :
(prHOFDH, <prHOFDH>)
(String, Text)
History of elective abortion ?
(prHOEA, <prHOEA>)
No  (1)
Yes (2)
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(Integer, RadioCheckbox)
, how many :
(prHOEAH, <prHOEAH>)
(String, Text)
History of therapeutic abortion ?
(prHOTA, <prHOTA>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, how many :
(prHOTAH, <prHOTAH>)
(String, Text)
History of birth defect ?
(prHOBD, <prHOBD>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, how many :
(prHOBDH, <prHOBDH>)
(String, Text)
History of congenital anomaly ?
(prHOCA, <prHOCA>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, how many :
(prHOCAH, <prHOCAH>)
(String, Text)
RELEVANT DRUG(S) OTHER THAN HRA PHARMA EMERGENCY CONTRACEPTION RECEIVED
DURING PREGANCY
Medication Name
(prMnm1, <prMnm1>)
(String, Text)
Indication
(prInd1, <prInd1>)
(String, Text)
Daily dose
(prDaDos1, <prDaDos1>)
(String, Text)
Route of administration
(prRad1, <prRad1>)
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(String, Text)
Perios of exposure during pregnancy
(prPOEx1, <prPOEx1>)
(Integer, RadioCheckbox)
1st trim.  (1)
2nd trim.  (2)
3rd trim.   (3)
Throughout pregnancy  (4)
Unknown (5)
Medication Name
(prMnm2, <prMnm2>)
(String, Text)
Indication
(prInd2, <prInd2>)
(String, Text)
Daily dose
(prDaDos2, <prDaDos2>)
(String, Text)
Route of administration
(prRad2, <prRad2>)
(String, Text)
Period of exposure during pregnancy
(prPOEx2, <prPOEx2>)
(Integer, RadioCheckbox)
1st trim.  (1)
2nd trim.  (2)
3rd trim.   (3)
Throughout pregnancy  (4)
Unknown (5)
Medication Name
(prMnm3, <prMnm3>)
(String, Text)
Indication
(prInd3, <prInd3>)
(String, Text)
Daily dose
(prDaDos3, <prDaDos3>)
(String, Text)
Route of administration
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(prRad3, <prRad3>)
(String, Text)
Perios of exposure during pregnancy
(prPOEx3, <prPOEx3>)
(Integer, RadioCheckbox)
1st trim.  (1)
2nd trim.  (2)
3rd trim.   (3)
Throughout pregnancy  (4)
Unknown (5)
Recreational drug use
Tobacco
(prTab, <prTab>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Estimated weekly dose
(prTabD, <prTabD>)
(String, Text)
Period of exposure during pregnancy
(prTabP, <prTabP>)
(Integer, RadioCheckbox)
1st trim.  (1)
2nd trim.  (2)
3rd trim.   (3)
Throughout pregnancy  (4)
Unknown (5)
Alcohol
(prAlc, <prAlc>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Estimated weekly dose
(prAlcD, <prAlcD>)
(String, Text)
Period of exposure during pregnancy
(prAlcP, <prAlcP>)
(Integer, RadioCheckbox)
1st trim.  (1)
2nd trim.  (2)
3rd trim.   (3)
Throughout pregnancy  (4)
Unknown (5)
Illicit drugs
(prDrg, <prDrg>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
Estimated weekly dose
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(prDrgD, <prDrgD>)
(String, Text)
Route of administration
(prDrgR, <prDrgR>)
(String, Text)
Period of exposure during pregnancy
(prDrgP, <prDrgP>)
(Integer, RadioCheckbox)
1st trim.  (1)
2nd trim.  (2)
3rd trim.   (3)
Throughout pregnancy  (4)
Unknown (5)
RELEVANT MEDICAL CONDITION(S) DURING PREGNANCY*
 *diabetes, hypertension or any other significant medical condition
Medical condition
(prMC1, <prMC1>)
(String, Text)
Start date
(prMCst1, <prMCst1>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Stop date
(prMCsp1, <prMCsp1>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
.
(prMCO1, <prMCO1>)
(Integer, RadioCheckbox)
Ongoing at time of pregnancy outcome (1)
Medical condition
(prMC2, <prMC2>)
(String, Text)
Start date
(prMCst2, <prMCst2>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Stop date
(prMCsp2, <prMCsp2>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
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.
(prMCO2, <prMCO2>)
(Integer, RadioCheckbox)
Ongoing at time of pregnancy outcome (1)
RESULTS OF SEROLOGY TESTS
Rubella test  Date and Result
(prRubT, <prRubT>)
(String, MultiLineText)
Toxoplasmosis test Date and Result
(prToxT, <prToxT>)
(String, MultiLineText)
PRENATAL TESTS
Type of test
(prPTtp1, <prPTtp1>)
(String, Text)
Date and Result
(prPTdt1, <prPTdt1>)
(String, MultiLineText)
Type of test
(prPTtp2, <prPTtp2>)
(String, Text)
Date and Result
(prPTdt2, <prPTdt2>)
(String, MultiLineText)
Type of test
(prPTtp3, <prPTtp3>)
(String, Text)
Date and Result
(prPTdt3, <prPTdt3>)
(String, MultiLineText)
Pregnancy Collection Form
 (emergency contraception)
 page : 3 of 6
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Patient ID: Initials
(prPIDin3, <prPIDin3>)
(String, Text)
Date of birth:
(prDOB3, <prDOB3>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
For internal use only :  Case No:HRA-
(prCsNo3, <prCsNo3>)
(String, Text)
TO COMPLETE IN CASE OF ELECTIVE ABORTION
Date of elective abortion (no medical reason - patient’s
elective choice):
(prDEA, <prDEA>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
Was an ultrasound performed
(prUper, <prUper>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, date:
(prUperD, <prUperD>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
What were the findings:
(prUfnd, <prUfnd>)
(String, MultiLineText)
Was there any evidence of heartbeat?
(prEvd, <prEvd>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
, reason (i.e. early stage of pregnancy):
(prEvdR, <prEvdR>)
(String, MultiLineText)
Fetus Crown Rump Length (CRL)………(mm)
(prCRL, <prCRL>)
(Integer, RadioCheckbox)
Not conclusive  (1)
Normal for gestational age (2)
Biparietal diameter (BPD)…….(mm)
(prBPD, <prBPD>)
(Integer, RadioCheckbox)
Not conclusive  (1)
Normal for gestational age (2)
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Please provide a copy of the medical report of this exam together with this completed form
Was a placental pathologic examination performed?
(prPthE, <prPthE>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, date:
(prPthED, <prPthED>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
What were the findings:
(prPthEF, <prPthEF>)
(String, MultiLineText)
Please provide a copy of the medical report of this exam together with this completed form
Was a pathologic examination of the products of
conception performed
(prPthE2, <prPthE2>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, date:
(prPthE2D, <prPthE2D>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
What were the findings:
(prPthE2F, <prPthE2F>)
(String, MultiLineText)
Please provide a copy of the medical report(s) of this exam together with this completed form
 Thank you for completing this form
br> Pregnancy Collection Form
 (emergency contraception)
 page : 4 of 6
Patient ID: Initials
(prPIDin4, <prPIDin4>)
(String, Text)
Date of birth:
(prDOB4, <prDOB4>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
For internal use only :  Case No:HRA-
(prCsNo4, <prCsNo4>)
(String, Text)
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TO COMPLETE IN CASE OF CONGENITAL ANOMALY
Pregnancy term (in weeks) at time of diagnosis:
(prTrmDg, <prTrmDg>)
(String, Text)
Pregnancy term (in weeks) at time of delivery:
(prTrmDl, <prTrmDl>)
(String, Text)
Number of children born :
(prNoCb, <prNoCb>)
(String, Text)
Delivery method :
(prDMth, <prDMth>)
(Integer, RadioCheckbox)
Vaginal  (1)
Caesarean (2)
LIST OF CONGENITAL ANOMALIES
CHILD 1
(prCong1, <prCong1>)
(String, Text)
CHILD 2
(prCong2, <prCong2>)
(String, Text)
CHILD 3
(prCong3, <prCong3>)
(String, Text)
CHILD 1 RELATIONSHIP TO
EMERGENCYCONTRACEPTION INTAKE
 (certain/probable/possible/unlikely/not related)
(prRlECI1, <prRlECI1>)
(String, Text)
POSSIBLE CAUSES
 1=MATERNAL AGE, 2=UNKNOWN
 3=OTHER, SPECIFY
(prPosCs1, <prPosCs1>)
(String, Text)
CHILD 2 RELATIONSHIP TO
EMERGENCYCONTRACEPTION INTAKE
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 (certain/probable/possible/unlikely/not related)
(prRlECI2, <prRlECI2>)
(String, Text)
POSSIBLE CAUSES
 1=MATERNAL AGE, 2=UNKNOWN
 3=OTHER, SPECIFY
(prPosCs2, <prPosCs2>)
(String, Text)
CHILD 3 RELATIONSHIP TO
EMERGENCYCONTRACEPTION INTAKE
 (certain/probable/possible/unlikely/not related)
(prRlECI3, <prRlECI3>)
(String, Text)
POSSIBLE CAUSES
 1=MATERNAL AGE, 2=UNKNOWN
 3=OTHER, SPECIFY
(prPosCs3, <prPosCs3>)
(String, Text)
APGAR SCORES
CHILD 1 APGAR1 MIN
(prAp1_1, <prAp1_1>)
(String, Text)
APGAR 5 MIN
(prAp5_1, <prAp5_1>)
(String, Text)
CHILD 2 APGAR1 MIN
(prAp1_2, <prAp1_2>)
(String, Text)
APGAR 5 MIN
(prAp5_2, <prAp5_2>)
(String, Text)
CHILD 3 APGAR1 MIN
(prAp1_3, <prAp1_3>)
(String, Text)
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APGAR 5 MIN
(prAp5_3, <prAp5_3>)
(String, Text)
Please describe below any maternal and/or family history
of congenital anomaly
(prHist, <prHist>)
(String, MultiLineText)
Please describe below any other significant maternal
and/or family history
(prSgMat, <prSgMat>)
(String, MultiLineText)
Other comments
(prOcom, <prOcom>)
(String, MultiLineText)
Thank you for completing this form.
Pregnancy Collection Form
 (emergency contraception)
 page : 5 of 6
Patient ID: Initials
(prPIDin5, <prPIDin5>)
(String, Text)
Date of birth:
(prDOB5, <prDOB5>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
For internal use only :  Case No:HRA-
(prCsNo5, <prCsNo5>)
(String, Text)
TO COMPLETE IN CASE OF NEONATAL DEATH
Pregnancy term (in weeks) :
(prTrmDl5, <prTrmDl5>)
(String, Text)
Number of children born :
(prNoCb5, <prNoCb5>)
(String, Text)
Delivery method :
Vaginal  (1)
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(prDMth5, <prDMth5>)
(Integer, RadioCheckbox)
Caesarean (2)
CHILD 1 AGE OF NEONATE AT DEATH
(prNeoA1, <prNeoA1>)
(String, Text)
CAUSE OF DEATH
(prNeoC1, <prNeoC1>)
(String, Text)
RELATIONSHIP TO EMERGENCY CONTRACEPTION
INTAKE
 (certain/probable/possible/unlikely/not related)
(prNeoR1, <prNeoR1>)
(String, Text)
AUTOPSY PERFORMED
 (YES/NO)*
(prNeoAu1, <prNeoAu1>)
(String, Text)
CHILD 2 AGE OF NEONATE AT DEATH
(prNeoA2, <prNeoA2>)
(String, Text)
CAUSE OF DEATH
(prNeoC2, <prNeoC2>)
(String, Text)
RELATIONSHIP TO EMERGENCY CONTRACEPTION
INTAKE
 (certain/probable/possible/unlikely/not related)
(prNeoR2, <prNeoR2>)
(String, Text)
AUTOPSY PERFORMED
 (YES/NO)*
(prNeoAu2, <prNeoAu2>)
(String, Text)
CHILD 3 AGE OF NEONATE AT DEATH
(prNeoA3, <prNeoA3>)
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(String, Text)
CAUSE OF DEATH
(prNeoC3, <prNeoC3>)
(String, Text)
RELATIONSHIP TO EMERGENCY CONTRACEPTION
INTAKE
 (certain/probable/possible/unlikely/not related)
(prNeoR3, <prNeoR3>)
(String, Text)
AUTOPSY PERFORMED
 (YES/NO)*
(prNeoAu3, <prNeoAu3>)
(String, Text)
APGAR SCORES
CHILD 1 APGAR1 MIN
(prApN1_1, <prApN1_1>)
(String, Text)
APGAR 5 MIN
(prApN5_1, <prApN5_1>)
(String, Text)
CHILD 2 APGAR1 MIN
(prApN1_2, <prApN1_2>)
(String, Text)
APGAR 5 MIN
(prApN5_2, <prApN5_2>)
(String, Text)
CHILD 3 APGAR1 MIN
(prApN1_3, <prApN1_3>)
(String, Text)
APGAR 5 MIN
(prApN5_3, <prApN5_3>)
(String, Text)
Please describe below any maternal and/or family history
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of congenital anomaly
(prHistN, <prHistN>)
(String, MultiLineText)
Please describe below any other significant maternal
and/or family history
(prSgMatN, <prSgMatN>)
(String, MultiLineText)
Other comments
(prOcomN, <prOcomN>)
(String, MultiLineText)
Thank you for completing this form.
Pregnancy Collection Form
 (emergency contraception)
 page : 6 of 6
Patient ID: Initials
(prPIDin6, <prPIDin6>)
(String, Text)
Date of birth:
(prDOB6, <prDOB6>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
For internal use only :  Case No:HRA-
(prCsNo6, <prCsNo6>)
(String, Text)
TO COMPLETE IN CASE OF FOETAL LOSS
Pregnancy term (in weeks)
(prTrmDl6, <prTrmDl6>)
(String, Text)
Number of fetus :
(prNoCb6, <prNoCb6>)
(String, Text)
FACTORS THAT MAY HAVE HAD AN IMPACT ON
FOETAL LOSS
 1
(prFctLs1, <prFctLs1>)
(String, Text)
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2
(prFctLs2, <prFctLs2>)
(String, Text)
3
(prFctLs3, <prFctLs3>)
(String, Text)
4
(prFctLs4, <prFctLs4>)
(String, Text)
5
(prFctLs5, <prFctLs5>)
(String, Text)
In case of ectopic pregnancy, please specify below:
(prEctc, <prEctc>)
(String, MultiCheckbox)
Salpingitis or known tubal anomaly  (1)
Previous ectopic pregnancy  (2)
Previous tubal seurgery (3)
RELATIONSHIP BETWEEN FOETAL LOSS AND
EMERGENCY CONTRACEPTION INTAKE
 (certain / probable / possible / unlikely / not related)
(prLossR, <prLossR>)
(String, Text)
Please describe below any maternal and/or family history
of foetal loss
(prHistL, <prHistL>)
(String, MultiLineText)
Please describe below any other significant maternal
and/or family history
(prSgMatL, <prSgMatL>)
(String, MultiLineText)
FOETAL LOSS COMPLICATIONS
Any vaginal bleeding?
(prVB, <prVB>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, please specify:
(prVBS, <prVBS>)
(Integer, RadioCheckbox)
Spotting  (1)
Regular  (2)
Heavy (3)
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Duration of bleedings:
(prVBD, <prVBD>)
(String, Text)
Were the bleedings clinically excessive?
(prVBex, <prVBex>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
Need for curettage?
(prNeCu, <prNeCu>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, please specify the gestational age:
(prNeCuS, <prNeCuS>)
(String, Text)
The curettage was performed:
(prNeCuP, <prNeCuP>)
(Integer, RadioCheckbox)
following the usual protocol  (1)
because you were worried about excessive bleeding (2)
Any infection?
(prInfc, <prInfc>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
Location of infection
(prInfcL, <prInfcL>)
(String, Text)
Infectious agent
(prInfcI, <prInfcI>)
(String, Text)
Treatment given
(prInfcT, <prInfcT>)
(String, Text)
Was the infection a complication of pregnancy loss?
(prInfcC, <prInfcC>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
Any other complication?
(prOthC, <prOthC>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
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, please describe:
(prOthCD, <prOthCD>)
(String, MultiLineText)
Was a pathologic examination of the products of
conception performed
(prExPr, <prExPr>)
(Integer, RadioCheckbox)
No  (1)
Yes (2)
, date:
(prExPrD, <prExPrD>)
(PartialDate, PartialDate)
(dd[UNK]-MMM[UNK]-yyyy)
What were the findings:
(prExPrF, <prExPrF>)
(String, MultiLineText)
Please Provide a copy of the medical report(s) of this
exam together with this completed form
 OTHER COMMENTS
(prOcom6, <prOcom6>)
(String, MultiLineText)
Thank you for completing this form.
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25 FINAL SUBJECT DISPOSITION – ENROLLED SUBJECTS
(fDisp, <fDisp>)
25 FINAL SUBJECT DISPOSITION – ENROLLED SUBJECTS
Date of Final Disposition
(fDispDt, <fDispDt>)
(Date, Text)
(dd-MMM-yyyy)
Interviewer: Select a final disposition for the subject.
<brCheck only one
(fDispo, <fDispo>)
(Integer, RadioCheckbox)
Completed subject (all data collected)  (1)
Completed subject subject with partial missing data:   (2)
Lost to follow-up  (3)
Subject withdrew consent (do not contact)  (4)
Subject withdrew due to an AE   (5)
Subject withdrew for other reasons.   (6)
Other:   (7)
Subject death (8)
If Other, please specify:
(fDispoO, <fDispoO>)
(String, Text)
.
(fDispoW, <fDispoW>)
(Integer, RadioCheckbox)
Investigator decision  (1)
Subject Physician decision  (2)
Protocol violation (3)
.
(fDispoM2, <fDispoM2>)
(String, MultiCheckbox)
PG test results unknown  (1)
PG test results known, but test was taken prior to EOS
window;, further subject data unable to be collected via
follow-up  (5)
Missing Week 2 interview  (2)
Missing Week 6 interview  (3)
Missing EOS interview (4)
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Sub Forms
*LIVER-SPECIFIC ADVERSE EVENT NURSE INTERVIEW*
*LIVER TEST*
*LIVER TEST 2*
 
Liver Follow-up
(livF, <livF>)
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LIVER-SPECIFIC ADVERSE EVENT NURSE INTERVIEW
(livFU, <livFU>)
SECTION 2:  LIVER-SPECIFIC ADVERSE EVENT NURSE INTERVIEW
S2:Q1  Interviewer: Please indicate if this is a current
subject or a completed/withdrawn subject?
(subType, <subType>)
(Integer, RadioCheckbox)
Current as of 1/18/2018  (1)
Completed/Withdrawn as of 1/18/2018 (2)
S2:Q2  If Box 1 to S2:Q1 Interviewer: Please indicate if this
is being conducted as part of a regularly scheduled
interview or an extra interview?
(subTypeA, <subTypeA>)
(Integer, RadioCheckbox)
Extra:  Before Week 2  (1)
Regular:  Week 2  (2)
Extra:  Between Week 2 and Week 6  (3)
Regular:  Week 6/EOS  (4)
Extra:  After Week 6/EOS (5)
If Box 1 to S2:Q1 and Box 1,3 or 5 to S2:Q2 Read: Hello,
my name is _______________. I am a nurse from PEGUS
Research calling about the study that you enrolled in at
(study site) on (date of enrollment).  This is not one of the
previously scheduled follow-up interviews as part of the
study, but I have a few questions for you and some
information about the study. This usually takes about 10
minutes and you will be paid an additional $25 for your
time.  May I go ahead now? (If no, ask when would be a
good time to call back)
(lAEint1, <lAEint1>)
(String, PlainText)
If Box 2 to S2:Q1 Read: Hello, my name is
_______________. I am a nurse from PEGUS Research
calling about the study that you participated in beginning
on (date of enrollment).  I know that you have finished your
participation, however the US Food and Drug
Administration asked us to recontact subjects who were in
the study to ask a few additional questions. This usually
takes about 10 minutes and you will be paid an additional
$25 for your time.  May I go ahead now? (If no, ask when
would be a good time to call back)
(lAEint2, <lAEint2>)
(String, PlainText)
Subject Number:
(lAESub, <lAESub>)
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(String, Text)
Date of interview:
(lAEDT, <lAEDT>)
(Date, Text)
(dd-MMM-yyyy)
Adverse Event Trigger Questions
 These questions should be asked of everybody to determine if any adverse events need to be recorded.
Do not repeat these questions if being conducted as part of a regularly scheduled interview.
 Read: First, I’m going to ask you some questions about any health problems you may have had since you
enrolled in the study.
 Since you enrolled in the ella study, have you been to the doctor for any reason you haven’t previously told
us about?
 Since you enrolled in the ella study, have you developed any new medical problems you haven’t previously
told us about?
 Since you enrolled in the ella study, have you been to a hospital as a patient for any reason that you
haven’t previously told us about?
 Based on the responses to all questions, go to the Adverse Events Form and complete as necessary.
S2:Q3  Interviewer:  Did the subject, during this interview
or any previous interview, specifically report liver-related
adverse events or report any of the following non-specific
symptoms:  fatigue, weakness, nausea, vomiting, poor
appetite, abdominal pain (right upper quadrant pain or
tenderness), jaundice, dark urine, fever, rash, or itching
that is not adequately explained by another reported
adverse event?
(lAErep, <lAErep>)
(Integer, RadioCheckbox)
Yes  If Yes to S2:Q3 , go to the Adverse Events Form
and complete as necessary.  (1)
No (2)
If Yes to S2:Q3 , go to the Adverse Events Form and complete as necessary.
S2:Q4  Since you enrolled in the ella study, have you had
any of the following symptoms?
 Read answer options and check Yes or No for each A
Unusual fatigue
(lAEsA, <lAEsA>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
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(lAEsAref, <lAEsAref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
B Weakness
(lAEsB, <lAEsB>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsBref, <lAEsBref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
C Nausea
(lAEsC, <lAEsC>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsCref, <lAEsCref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
D Vomiting
(lAEsD, <lAEsD>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsDref, <lAEsDref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
E Loss of appetite
(lAEsE, <lAEsE>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsEref, <lAEsEref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
F Abdominal pain below your ribs on the right side
Yes    (1)
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(lAEsF, <lAEsF>)
(Integer, RadioCheckbox)
No (2)
If yes, select AE
(lAEsFref, <lAEsFref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
G Jaundice, or yellowing of the skin or eyes
(lAEsG, <lAEsG>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsGref, <lAEsGref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
H Dark urine
(lAEsH, <lAEsH>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsHref, <lAEsHref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
I Fever
(lAEsI, <lAEsI>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsIref, <lAEsIref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
J Rash
(lAEsJ, <lAEsJ>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsJref, <lAEsJref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
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Sample reference 3 ( )
(/use/aesum/ae[n])
K Itching
(lAEsK, <lAEsK>)
(Integer, RadioCheckbox)
Yes    (1)
No (2)
If yes, select AE
(lAEsKref, <lAEsKref>)
(Reference, Select)
Sample reference 1 ( )
Sample reference 2 ( )
Sample reference 3 ( )
(/use/aesum/ae[n])
If Yes to any of  S2:Q4 , go to the Adverse Events Form
and complete as necessary.
  S2:Q5  If yes to any of S2:Q4: Interviewer:  Are any of the
above ongoing?
 Do not read answer options
 Check only one
(lAEong, <lAEong>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know (3)
S2:Q6  If yes to any of S2:Q4: Have you spoken to a
healthcare provider about those symptoms?
 Do not read answer options
 Check only one
(lAEspk, <lAEspk>)
(Integer, RadioCheckbox)
Yes  (1)
No  (2)
Don’t know (3)
S2:Q6a  If S2:Q6 =Yes: What did your healthcare provider
tell you about it?
  Probe: Probe to get as much information as possible with
neutral questions such as “did they give you a diagnosis?”
or “anything else?”
 Record verbatim response
(lAEtel, <lAEtel>)
(String, MultiLineText)
If Yes to S2:Q5   and No to S2:Q6 Read: Since you are
continuing to have those symptoms, we recommend you
see a healthcare provider about them.
(lAEhc, <lAEhc>)
(String, PlainText)
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S2:Q7  Do you have any tablets of the study drug ella left,
or any packaging from the study product?
 Do not read answer options
 Check only one
(lAEtab, <lAEtab>)
(Integer, RadioCheckbox)
Yes, drug  (1)
Yes, packaging only  (2)
No  (3)
Don’t know (4)
If Box 1 to S2:Q7 Read: Please do not take any more
tablets of the study drug that you still have. Also, please
return any unused tablets and packaging to PEGUS
Research right away using the envelope provided to you
when you enrolled. You will be reimbursed for your unused
study drug.
(tabTx1, <tabTx1>)
(String, PlainText)
If Box 2 to S2:Q7  Read: Please return any packaging to
PEGUS Research right away using the envelope provided
to you when you enrolled.
(tabTx2, <tabTx2>)
(String, PlainText)
If Box 2 to S2:Q1 Read: The reason that the FDA asked us
to recontact you to answer these questions is because of
four reports of serious liver injury in Europe among women
taking Esmya, which is ulipristal acetate 5 mg every day to
treat uterine fibroids. It is unknown at this time whether that
liver damage is related to that medicine or not.       No
cases of serious liver injury have been reported with ella,
which is ulipristal acetate 30 mg, when used for
emergency contraception.  Thank you for your time today.
Your compensation for this interview will come to you in
the (mail in the next 2 weeks) or (as an e-card in your
email in the next week).  End of call.
(tabTx3, <tabTx3>)
(String, PlainText)
If Box 1 to S2:Q1 Read: FDA asked us to contact you to
answer these questions because of four reports of serious
liver injury in Europe among women taking Esmya, which
is ulipristal acetate 5 mg every day to treat uterine fibroids
It is unknown at this time whether that liver damage is
related to that medicine or not.  No cases of serious liver
Yes  (1)
No   (2)
Don’t know / Refused (3)
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injury have been reported with ella, which is ulipristal
acetate 30 mg, when used for emergency contraception
However, because of this concern, FDA also asked us to
conduct a blood test to check the liver function of all
subjects who are still participating or recently finished
participating in the study.  This would involve another visit
to the clinic where you enrolled in the study to have some
blood drawn.  The visit would be brief, and you would be
compensated $150 for your time to do this.
  S2:Q8  If Box 1 to S2:Q1  Are you willing to return to the
site for a blood test to check your liver function?
 Do not read answer options
 Check only one
(lAErtn, <lAErtn>)
(Integer, RadioCheckbox)
If No to S2:Q8 skip to the end of the interview, just after
S2:Q12
(lAErtnN, <lAErtnN>)
(String, PlainText)
If Yes to S2:Q8 Read: Great, thank you.  I have just a few
additional questions for you and then I will give you
instructions about how to schedule an appointment to go
back to the site for the blood draw.
(lAErtnY, <lAErtnY>)
(String, PlainText)
S2:Q9  Have you ever had any kind of liver disease?
 Do not read answer options
 Check only one
(lAEld, <lAEld>)
(Integer, RadioCheckbox)
Yes  (1)
No   (2)
Don’t know (3)
S2:Q9a  If S2:Q9 =Yes: Please tell me about that.
  Probe: Probe to get as much information as possible with
neutral questions such as “what was your diagnosis?”
“when were you diagnosed”, “do you still have it?”, etc.
 Record verbatim response
(lAEldA, <lAEldA>)
(String, MultiLineText)
S2:Q10  Do you currently have or have you been
Yes  (1)
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diagnosed with any of the following:
 Read answer options and check Yes or No for each
 A Hepatitis A
(lAEdA, <lAEdA>)
(Integer, RadioCheckbox)
No (2)
start date
(lAEdAsD, <lAEdAsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdAeD, <lAEdAeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
(lAEdAos, <lAEdAos>)
(String, MultiLineText)
B Hepatitis B
(lAEdB, <lAEdB>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdBsD, <lAEdBsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdBeD, <lAEdBeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
(lAEdBos, <lAEdBos>)
(String, MultiLineText)
C Hepatitis C
(lAEdC, <lAEdC>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdCsD, <lAEdCsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdCeD, <lAEdCeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
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(lAEdCos, <lAEdCos>)
(String, MultiLineText)
D Fatty liver disease
(lAEdD, <lAEdD>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdDsD, <lAEdDsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdDeD, <lAEdDeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
(lAEdDos, <lAEdDos>)
(String, MultiLineText)
E Diabetes
(lAEdE, <lAEdE>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdEsD, <lAEdEsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdEeD, <lAEdEeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
(lAEdEos, <lAEdEos>)
(String, MultiLineText)
F High cholesterol
(lAEdF, <lAEdF>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdFsD, <lAEdFsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdFeD, <lAEdFeD>)
(dd-MMM-yyyy)
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(Date, Text)
severity, other specifics
(lAEdFos, <lAEdFos>)
(String, MultiLineText)
G Heart attack
(lAEdG, <lAEdG>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdGsD, <lAEdGsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdGeD, <lAEdGeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
(lAEdGos, <lAEdGos>)
(String, MultiLineText)
H Other heart disease
(lAEdH, <lAEdH>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdHsD, <lAEdHsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
(lAEdHeD, <lAEdHeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
(lAEdHos, <lAEdHos>)
(String, MultiLineText)
I Any autoimmune disease
(lAEdI, <lAEdI>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
start date
(lAEdIsD, <lAEdIsD>)
(Date, Text)
(dd-MMM-yyyy)
end date
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(lAEdIeD, <lAEdIeD>)
(Date, Text)
(dd-MMM-yyyy)
severity, other specifics
(lAEdIos, <lAEdIos>)
(String, MultiLineText)
S2:Q11  Do you drink alcohol?
 Do not read answer options
 Check only one
(lAEalc, <lAEalc>)
(Integer, RadioCheckbox)
Yes  (1)
No   (2)
Don’t know (3)
S2:Q11a  If S2:Q11 =Yes: How much and how often do
you drink alcohol?
  Probe: Probe to get as much information as possible,
including how many days of the week do they drink, how
much do they typically drink when they do drink, and how
often they drink to the point that they would consider
themselves drunk, etc.
 Record verbatim response
(lAEalcA, <lAEalcA>)
(String, MultiLineText)
S2:Q12  If Box 1, Box 2, or Box 3 to S2:Q2: Since you
enrolled in this study on (date of enrollment), have you
started taking any new medications?
 Do not read answer options
 Check only one
Complete Concomitant Medication Form
 Consider new medications or changes in medications
reported, and based on the responses to all questions, go
to the Adverse Events Form and complete as necessary.
(lAEnew, <lAEnew>)
(Integer, RadioCheckbox)
Yes  (1)
No   (2)
Don’t know (3)
If Yes to S2:Q8  and Site Number IN (1002, 1004, 1005,
1006, 1007, 1008, 1015, 1016, 1017, 1018, 1037, 1038)
Read:  A member of the study staff at the clinic where you
enrolled in the study will call you to schedule your
appointment to have your blood drawn. This will be done
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free of charge, and you will be compensated $150 for your
time.
(lAEeTx1, <lAEeTx1>)
(String, PlainText)
If Yes to S2:Q8  and Site Number IN (1003, 1010, 1011,
1012, 1013, 1019, 1020, 1021, 1022, 1023, 1028, 1029,
1030, 1034, 1035, 1036, 1039, 1040) Read: At the end of
this call, I will transfer you over to the clinic where you
enrolled in the study so you can schedule your
appointment to have your blood drawn. This will be done
free of charge, and you will be compensated $150 for your
time. If no one answers the phone when I transfer you,
please leave a voicemail and a study staff member will call
you back as soon as possible.
(lAEeTx2, <lAEeTx2>)
(String, PlainText)
If Box 2 or 4 to S2:Q2 , finish regularly scheduled interview
(lAEeTx3, <lAEeTx3>)
(String, PlainText)
If Box 1 to S2:Q2 Read: That concludes our telephone
interview for today.  Your compensation for this interview
will come to you in the (mail in the next 2 weeks) or (as an
e-card in your email in the next week).  A nurse from
PEGUS Research will contact you when it is time for your
2-week interview.  Thank you for your time and have a nice
day.
(lAEeTx4, <lAEeTx4>)
(String, PlainText)
If Box 3 to S2:Q2 Read: That concludes our telephone
interview for today.  Your compensation for this interview
will come to you in the (mail in the next 2 weeks) or (as an
e-card in your email in the next week).  A nurse from
PEGUS Research will contact you when it is time for your
6-week interview.  Remember that the pregnancy test that
you were given at the site will need to be taken just before
that interview, on the date indicated on the reminder card
you received when you enrolled.  Thank you for your time
and have a nice day.
(lAEeTx5, <lAEeTx5>)
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(String, PlainText)
If Box 5 to S2:Q2 Read: That concludes our telephone
interview for today.  Your compensation for this interview
will come to you in the (mail in the next 2 weeks) or (as an
e-card in your email in the next week).    Thank you for
your time and have a nice day.
(lAEeTx6, <lAEeTx6>)
(String, PlainText)
.
(lAENC, <lAENC>)
(Integer, RadioCheckbox)
Not contacted  (1)
Refused Interview (2)
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LIVER TEST
(livTest, <livTest>)
SECTION 2:  LIVER TESTING INFORMED CONSENT
  Read: Thank you for coming in today. I first want to give you some information about why you are here
today. The United States Food and Drug Agency, or FDA, asked us to conduct a blood test to check the
liver function of all subjects who are still participating or recently finished participating in the LIBRella
emergency contraception study. The FDA’s concern comes from four reports of serious liver injury in Europe
among women taking Esmya, which is ulipristal acetate 5 mg taken every day to treat uterine fibroids. It is
unknown at this time whether that liver damage is related to that medicine or not.  No cases of serious liver
injury have been reported with ella, which is ulipristal acetate 30 mg, when used for emergency
contraception. You are here today to have your blood drawn for a blood liver function panel test.
  Read: I would like you to read this Informed Consent Document that explains all about your participation in
this study procedure today.  Please read it very carefully; take as much time as you need.  If you have any
questions, please ask me.  Also, please don’t sign anything until we have a chance to talk after you’ve read
it.
S2:Q1  Interviewer: Was the subject allowed to ask
questions about the study and were questions addressed
and answered to the subject’s satisfaction prior to
obtaining written informed consent?
(t1ask, <t1ask>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating. (2)
S2:Q2  Interviewer: Did the subject (or parent/guardian of
an adolescent subject) sign the informed consent
document
(t1ic, <t1ic>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating. (2)
S2:Q2a  If Yes to S2:Q2: Record the date of consent
signature.
   (DD/MMM/YYYY)
(t1icDt, <t1icDt>)
(Date, Text)
(dd-MMM-yyyy)
S2:Q2b  If Yes to S2:Q2: Record first initial and last name
of study staff member conducting consent as qualified per
the Site Signature and Responsibility Log.
(t1icInt, <t1icInt>)
(String, Text)
S2:Q3  Interviewer, if subject is ≤XX years old or enrolls
Yes: Continue  (1)
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with a parent/guardian present: Did the adolescent subject
sign assent on the informed consent document?
(t1ass, <t1ass>)
(Integer, RadioCheckbox)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating. (2)
S2:Q3a  If Yes to S2:Q3: Record the date of consent
signature.
   (DD/MMM/YYYY)
(t1assDt, <t1assDt>)
(Date, Text)
(dd-MMM-yyyy)
SECTION 3:  BLOOD COLLECTION
 Read: I have a few questions for you before we collect
your blood sample.
  S3:Q1  Have you used alcohol in the past week?
(t1alc, <t1alc>)
(Integer, RadioCheckbox)
Yes  (1)
No (2)
S3:Q1a  If Yes to S3:Q1 : How many days in the last week
did you use alcohol?
    days
(t1alcA, <t1alcA>)
(String, Text)
S3:Q1b  If Yes to S3:Q1 : How many drinks have you had
in the past week?
  Interviewer: please quantify intake in “standard” drinks
(where 1 standard drink=12 fl oz of regular beer/8 fl oz of
malt liquor/5 fl oz of table wine/1.5 fl oz of distilled spirits)
  alcohol units (standard drinks)
(t1alcB, <t1alcB>)
(String, Text)
S3:Q2  Have you used any products containing
acetaminophen, which is the medicine in Tylenol and a
number of other painkillers and cold preparations, in the
past week?
(t1ace, <t1ace>)
(Integer, RadioCheckbox)
Yes:   (1)
No (2)
S3:Q2a  If Yes to S3:Q2: How many times in the last week
did you use acetaminophen?
    times
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(t1aceA, <t1aceA>)
(String, Text)
Read: As we just talked about while going over the study
procedure information, I (or another member of the study
staff) will now collect a sample of your blood.
  S3:Q3  Interviewer: was the blood sample collected?
(t1bld, <t1bld>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No: Specify: (2)
Specify:
(t1bldS, <t1bldS>)
(Integer, RadioCheckbox)
Study staff was unable to collect the blood sample.
STOP here.  Subject does not qualify to continue.
Compensate subject.  (1)
Subject declined to provide a blood sample. STOP here.
Subject does not qualify to continue. (2)
S3:Q3a  If Yes to S3:Q3: Record the date the blood
sample was collected.
   (DD/MMM/YYYY)
(t1bldDt, <t1bldDt>)
(Date, Text)
(dd-MMM-yyyy)
Read: Thank you.  Your blood sample will be sent to a
laboratory for testing. It will take several days for us to
obtain the results. If your results are outside of the normal
ranges, a study staff member will contact you via phone
and you may be asked to return for another blood liver
function panel test in several weeks and to answer some
additional questions related to your liver function test
results.
  Read: Your compensation for participating in this study
procedure is a $150 prepaid Visa card. Please note that it
expires in a few months.
 Verify that script was read and compensate subject
(t1intScr, <t1intScr>)
(Integer, RadioCheckbox)
Yes (1)
Please record the last 5 digits from the card used to
compensate the subject, complete the compensation
acknowledgment form with subject signature to document
receipt:
(t1Cver, <t1Cver>)
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(Integer, Text)
Please re-enter the last 5 digits from the card used to
compensate the subject:
(t1CverV, <t1CverV>)
(Integer, Text)
SECTION 4:  BLOOD LIVER FUNCTION PANEL
RESULTS
 Date of testing:
(t1bldDtT, <t1bldDtT>)
(Date, Text)
(dd-MMM-yyyy)
Date results entered:
(t1bldDtE, <t1bldDtE>)
(Date, Text)
(dd-MMM-yyyy)
Blood Liver Function Panel Results
 Test
 ALT
  Result
(t1altR, <t1altR>)
(String, Text)
 Normal Range: Lower Limit
(t1altL, <t1altL>)
(String, Text)
 Normal Range:  Upper Limit
(t1altU, <t1altU>)
(String, Text)
AST
  Result
(t1astR, <t1astR>)
(String, Text)
 Normal Range: Lower Limit
(t1astL, <t1astL>)
(String, Text)
 Normal Range:  Upper Limit
(t1astU, <t1astU>)
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(String, Text)
Alkaline Phosphatase
  Result
(t1alkR, <t1alkR>)
(String, Text)
 Normal Range: Lower Limit
(t1alkL, <t1alkL>)
(String, Text)
 Normal Range:  Upper Limit
(t1alkU, <t1alkU>)
(String, Text)
Total bilirubin
  Result
(t1bilR, <t1bilR>)
(String, Text)
 Normal Range: Lower Limit
(t1bilL, <t1bilL>)
(String, Text)
 Normal Range:  Upper Limit
(t1bilU, <t1bilU>)
(String, Text)
S4:Q1 Blood Liver Function Panel Results Disposition
(t1livF, <t1livF>)
(Integer, RadioCheckbox)
Testing completed: no follow-up testing needed  (1)
Testing completed: request follow-up testing  (2)
Testing not completed, explain: (3)
explain:
(t1livFe, <t1livFe>)
(String, Text)
SECTION 5:  SUBJECT NOTIFICATION OF RESULTS
S5:Q1  Box 1 checked in S4:Q1 :  Was subject notified that
her results were normal?
(t1not, <t1not>)
(Integer, RadioCheckbox)
Yes  (1)
No, explain: (2)
explain:
(t1note, <t1note>)
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(String, Text)
S5:Q1a  If Yes to S5:Q1 : Record the date subject was
informed.
   (DD/MMM/YYYY)
(t1notA, <t1notA>)
(Date, Text)
(dd-MMM-yyyy)
If results are outside of normal ranges (Box 2 checked in
S4:Q1 ), the following script will be used to contact the
subject by phone.
  Read: Hello, this is ___________ calling with the results
of your blood liver function panel testing. Your results were
higher than the normal range. It is seen in about 1 out of
every 10 women who are tested.  On its own, that is
generally  not a cause for concern and can be caused by a
number of things, including certain medications and
alcohol use.  .
 Verify that subject was notified of out of range results.
(t1rtnScr, <t1rtnScr>)
(Integer, RadioCheckbox)
Yes (1)
Read: We would like you to return to the research site to
have your blood drawn for repeat liver function testing.
This is free of charge to you, and you will be compensated
$150 for your time to do this.
  S5:Q2  If Box 2 checked in S4:Q1: Are you willing to
return for a follow-up liver function test?
  Do not read answer options
 Check only one
(t1rtn, <t1rtn>)
(Integer, RadioCheckbox)
Yes   (1)
No  (2)
Don’t know / Refused (3)
If Yes to S5:Q2  AND Site Number IN (1003, 1004, 1005,
1006, 1007, 1008, 1010, 1011, 1012, 1013, 1015, 1016,
1017, 1018, 1019, 1020, 1021, 1022, 1023, 1034, 1035,
1037, 1038, 1039, or 1040), read: Thank you, I can now
schedule an appointment for you.
(t1eTxt1, <t1eTxt1>)
(String, PlainText)
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If Yes to S5:Q2  AND Site Number IN (1002, 1028, 1029,
1030, or 1036), read: A member of the research staff at the
site will be calling you to schedule your appointment.
(t1eTxt2, <t1eTxt2>)
(String, PlainText)
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LIVER TEST 2
(livTest2, <livTest2>)
SECTION 2:  LIVER TESTING INFORMED CONSENT
  Read: Thank you for coming in today. I first want to give you some information about why you are here
today. The United States Food and Drug Agency, or FDA, asked us to conduct a blood test to check the
liver function of all subjects who are still participating or recently finished participating in the LIBRella
emergency contraception study. The FDA’s concern comes from four reports of serious liver injury in Europe
among women taking Esmya, which is ulipristal acetate 5 mg taken every day to treat uterine fibroids. It is
unknown at this time whether that liver damage is related to that medicine or not.  No cases of serious liver
injury have been reported with ella, which is ulipristal acetate 30 mg, when used for emergency
contraception. You are here today to have your blood drawn for a blood liver function panel test.
  Read: I would like you to read this Informed Consent Document that explains all about your participation in
this study procedure today.  Please read it very carefully; take as much time as you need.  If you have any
questions, please ask me.  Also, please don’t sign anything until we have a chance to talk after you’ve read
it.
S2:Q1  Interviewer: Was the subject allowed to ask
questions about the study and were questions addressed
and answered to the subject’s satisfaction prior to
obtaining written informed consent?
(t2ask, <t2ask>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating. (2)
S2:Q2  Interviewer: Did the subject (or parent/guardian of
an adolescent subject) sign the informed consent
document
(t2ic, <t2ic>)
(Integer, RadioCheckbox)
Yes: Continue  (1)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating. (2)
S2:Q2a  If Yes to S2:Q2: Record the date of consent
signature.
   (DD/MMM/YYYY)
(t2icDt, <t2icDt>)
(Date, Text)
(dd-MMM-yyyy)
S2:Q2b  If Yes to S2:Q2: Record first initial and last name
of study staff member conducting consent as qualified per
the Site Signature and Responsibility Log.
(t2icInt, <t2icInt>)
(String, Text)
S2:Q3  Interviewer, if subject is ≤XX years old or enrolls
Yes: Continue  (1)
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with a parent/guardian present: Did the adolescent subject
sign assent on the informed consent document?
(t2ass, <t2ass>)
(Integer, RadioCheckbox)
No: STOP here.  Subject does not qualify to continue.
Compensate subject for the visit and thank them for
participating. (2)
S2:Q3a  If Yes to S2:Q3: Record the date of consent
signature.
   (DD/MMM/YYYY)
(t2assDt, <t2assDt>)
(Date, Text)
(dd-MMM-yyyy)
SECTION 3:  BLOOD COLLECTION
 Read: I have a few questions for you before we collect
your blood sample.
  S3:Q1  Have you used alcohol in the past week?
(t2alc, <t2alc>)
(Integer, RadioCheckbox)
Yes:   (1)
No (2)
S3:Q1a  If Yes to S3:Q1 : How many days in the last week
did you use alcohol?
    days
(t2alcA, <t2alcA>)
(String, Text)
S3:Q1b  If Yes to S3:Q1 : How many drinks have you had
in the past week?
  Interviewer: please quantify intake in “standard” drinks
(where 1 standard drink=12 fl oz of regular beer/8 fl oz of
malt liquor/5 fl oz of table wine/1.5 fl oz of distilled spirits)
  alcohol units (standard drinks)
(t2alcB, <t2alcB>)
(String, Text)
S3:Q2  Have you used any products containing
acetaminophen, which is the medicine in Tylenol and a
number of other painkillers and cold preparations, in the
past week?
(t2ace, <t2ace>)
(Integer, RadioCheckbox)
Yes:   (1)
No (2)
S3:Q2a  If Yes to S3:Q2: How many times in the last week
did you use acetaminophen?
    times
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(t2aceA, <t2aceA>)
(String, Text)
Read: As we just talked about while going over the study
procedure information, I (or another member of the study
staff) will now collect a sample of your blood.
  S3:Q3  Interviewer: was the blood sample collected?
(t2bld, <t2bld>)
(Integer, RadioCheckbox)
Yes:   (1)
No: Specify: (2)
Specify:
(t2bldS, <t2bldS>)
(Integer, RadioCheckbox)
Study staff was unable to collect the blood sample.
STOP here.  Subject does not qualify to continue.
Compensate subject.  (1)
Subject declined to provide a blood sample. STOP here.
Subject does not qualify to continue. (2)
S3:Q3a  If Yes to S3:Q3: Record the date the blood
sample was collected.
   (DD/MMM/YYYY)
(t2bldDt, <t2bldDt>)
(Date, Text)
(dd-MMM-yyyy)
Read: Thank you.  Your blood sample will be sent to a
laboratory for testing. It will take several days for us to
obtain the results. If your results are outside of the normal
ranges, a study staff member will contact you via phone
and you may be asked to return for another blood liver
function panel test in several weeks and to answer some
additional questions related to your liver function test
results.
  Read: Your compensation for participating in this study
procedure is a $150 prepaid Visa card. Please note that it
expires in a few months.
 Verify that script was read and compensate subject
(t2intScr, <t2intScr>)
(Integer, RadioCheckbox)
Yes (1)
Please record the last 5 digits from the card used to
compensate the subject, complete the compensation
acknowledgment form with subject signature to document
receipt:
(t2Cver, <t2Cver>)
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(Integer, Text)
Please re-enter the last 5 digits from the card used to
compensate the subject:
(t2CverV, <t2CverV>)
(Integer, Text)
SECTION 4:  BLOOD LIVER FUNCTION PANEL
RESULTS
 Date of testing:
(t2bldDtT, <t2bldDtT>)
(Date, Text)
(dd-MMM-yyyy)
Date results entered:
(t2bldDtE, <t2bldDtE>)
(Date, Text)
(dd-MMM-yyyy)
Blood Liver Function Panel Results
 Test
 ALT
  Result
(t2altR, <t2altR>)
(String, Text)
 Normal Range: Lower Limit
(t2altL, <t2altL>)
(String, Text)
 Normal Range:  Upper Limit
(t2altU, <t2altU>)
(String, Text)
AST
  Result
(t2astR, <t2astR>)
(String, Text)
 Normal Range: Lower Limit
(t2astL, <t2astL>)
(String, Text)
 Normal Range:  Upper Limit
(t2astU, <t2astU>)
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(String, Text)
Alkaline Phosphatase
  Result
(t2alkR, <t2alkR>)
(String, Text)
 Normal Range: Lower Limit
(t2alkL, <t2alkL>)
(String, Text)
 Normal Range:  Upper Limit
(t2alkU, <t2alkU>)
(String, Text)
Total bilirubin
  Result
(t2bilR, <t2bilR>)
(String, Text)
 Normal Range: Lower Limit
(t2bilL, <t2bilL>)
(String, Text)
 Normal Range:  Upper Limit
(t2bilU, <t2bilU>)
(String, Text)
S4:Q1 Blood Liver Function Panel Results Disposition
(t2livF, <t2livF>)
(Integer, RadioCheckbox)
Testing completed: no follow-up testing needed  (1)
Testing completed: request follow-up testing  (2)
Testing not completed, explain: (3)
explain:
(t2livFe, <t2livFe>)
(String, Text)
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Form Architecture
 
Record
(1) SUBJECT NUMBER
(2) Programming Vars (DON’T MAKE VISIBLE)
(3) *Enrollment*
(1) *3  SCREENING*
(2) *4 PURCHASE QUESTION / 5 REASON FOR PURCHASE / 6 DEMO*
(3) *7 CURRENT / REGULAR RELEVANT MEDICATIONS AND ASSOCIATED CONDITIONS*
(4) *8 REALM TEST*
(5) *9 REALM TEEN TEST*
(6) *11 INFORMED CONSENT*
(7) *12 ENROLLMENT PREGNANCY TEST*
(8) *13 MEDICATIONS AT ENROLLMENT*
(9) *14 CONTACT INFORMATION AND PURCHASE TRANSACTION*
(10) *15 DRUG PURCHASE LOG*
(11) *16 DRUG RETURN LOG*
(12) *17 ENROLLMENT END-OF-STUDY QUESTIONS*
(13) *18 FINAL SUBJECT ENROLLMENT DISPOSITION*
(4) *Use*
(1) *19 NURSE FOLLOW-UP INTERVIEW (WEEK 2)*
(2) *20 CONCOMITANT MEDICATIONS*
(3) *21 NURSE FOLLOW-UP INTERVIEW (WEEK 6)*
(4) *22 END-OF-STUDY OR EARLY TERMINATION INTERVIEW*
(5) *23 END OF STUDY PREGNANCY TEST RESULTS*
(6) *24 AE / SAE / EIU FORMS*
[*24 AE / SAE / EIU FORMS*]
(7) *Pregnancy Collection Form (emergency contraception)*
(8) *25 FINAL SUBJECT DISPOSITION – ENROLLED SUBJECTS*
(5) *Liver Follow-up*
(1) *LIVER-SPECIFIC ADVERSE EVENT NURSE INTERVIEW*
(2) *LIVER TEST*
(3) *LIVER TEST 2*
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