Conditions: Opioid Induced Constipation
Keywords: Opioid Induced constipation, constipation, laxative, bowel movement, Movantik, Naloxegol
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 276
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.

Detailed description:
This study is a prospective, randomized, open-label crossover study consisting of a 1-week washout period, a 2-week treatment period, another 1-week washout and a final 2-week treatment period. The study will assess the overall patient preference Movantik versus Polyethylene Glycol 3350 for the treatment of their opioid-induced constipation. This study will also evaluate the reasons for patient preference (only among subjects who indicate a preference), patient global impression of change, and change in bowel function over the treatment periods measured by Bowel Function Index. Patient's bowel movement diary will also be collected during the study.

Arms:
arm 1: Crossover Group Movantik to Polyethylene Glycol 3350

2-period, 2-treatment cross-over model: Subjects will be randomized to Movantik during Treatment period 1 (2 weeks), then crossed over to receive Polyethylene Glycol 3350 for Treatment period 2 (2 weeks) after 1 week washout. arm 2: Crossover group Polyethylene Glycol 3350 to Movantik

2-period, 2-treatment cross-over model: Subjects will be randomized to Polyethylene Glycol 3350 during Treatment period 1 (2 weeks), then crossed over to receive Movantik for Treatment period 2 (2 weeks) after 1 week washout.

Interventions: intervention 1: Polyethylene Glycol 3350 intervention 2: Movantik
Intervention descriptions: intervention 1: Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.

Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours. intervention 2: Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.

Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.

Protocol document:
Prot_000.pdf: 
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SAP_001.pdf: 


Page 1 of 40
Statistical Analysis Plan
Study Code
D3820L00017
Version Number
1.0
Date
15 August 2017
A Phase IV, Randomized, Multi-Center, Open-Label, Prospective, 
Crossover Study to Evaluate Patient Preference of Movantik™versus 
Polyethylene Glycol 3350 (PEG 3350) for Opioid-Induced Constipation 
(OIC) Treatment
Protocol D3820L00017
Version 2.0
26 January 2017


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0  
Date 15 August 2017
Page 2 of 40
A Phase IV, Randomized, Multi-Center, Open-Label, Prospective, 
Crossover Study to Evaluate Patient Preference of Movantik™versus 
Polyethylene Glycol 3350 (PEG 3350) for Opioid-Induced Constipation 
(OIC) Treatment
Study Statistician
AZ Representative


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 3 of 40
TABLE OF CONTENTS
PAGE
Title page .......................................................................................................................1 
Signature of Study Statistician........................................................................................2 
TABLE OF CONTENTS ...............................................................................................3 
List Of Abbreviations.....................................................................................................6 
1. 
Study Design.................................................................................................................7 
2. 
Objectives .....................................................................................................................7 
3. 
Analysis Sets.................................................................................................................8 
3.1. 
Definition of analysis sets.................................................................................... 8 
3.1.1 Randomized Set............................................................................................. 8 
3.1.2 Full Analysis Set (FAS) ................................................................................. 8 
3.1.3 Per-protocol (PP) analysis set......................................................................... 8 
3.1.4 Safety analysis set.......................................................................................... 8 
4. 
Outcomes ......................................................................................................................9 
4.1 
Primary – Preference for OIC Treatment ............................................................. 9 
4.2 
Secondary............................................................................................................ 9 
4.2.1 Reason for Preference ........................................................................................... 9 
4.2.2 Impact of Movantik and PEG 3350 on OIC symptoms .......................................... 9 
4.2.2.1 Bowel Function Index (BFI)........................................................................ 9 
4.2.2.2 Patient Global Impression of Change (PGIC) .............................................. 9 
4.3 
Exploratory ......................................................................................................... 9 
4.3.1 BM/SBM frequency .............................................................................. 9 
4.3.2 Straining sensation .............................................................................. 10 
4.3.3 Bristol Stool Scale (BSS) .................................................................... 10 
4.3.4 Rescue Medication .............................................................................. 10 
4.4 
Safety................................................................................................................ 10 
4.4.1 Adverse Events ................................................................................... 10 
4.4.2 Vital Signs........................................................................................... 10 
4.4.3 Opioid Medication............................................................................... 10 
4.4.4 Study Medication Overdose................................................................. 11 
5. 
Analysis Methods........................................................................................................11 
5.1 General Principles.................................................................................................. 11 


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 4 of 40
5.2 Subject Disposition ................................................................................................ 12 
5.3 Protocol Deviations................................................................................................ 12 
5.4 Subject Demographics and Baseline Characteristics............................................... 13 
5.5 Exposure and Compliance...................................................................................... 14 
5.6 Primary Analyses................................................................................................... 14 
5.6.1 Preference for OIC Treatment ...................................................................... 14 
5.7 Secondary Analyses ............................................................................................... 15 
5.7.1. Reason for Preference ................................................................................. 15 
5.7.2 Impact of Movantik and PEG 3350 on OIC symptoms................................. 15 
5.7.2.1 Patient Global Impression of Change (PGIC) ................................... 16 
5.7.2.2 Bowel Function Index (BFI)............................................................. 16 
5.8 Exploratory Analyses............................................................................................. 17 
5.8.1 Bristol Stool Scale (BSS) ............................................................................. 17 
5.8.2 Straining Sensation ...................................................................................... 18 
5.8.3 BM/SBM Frequency.................................................................................... 18 
5.8.4 Rescue Medication....................................................................................... 18 
5.9 Subgroups.............................................................................................................. 19 
5.10 Safety................................................................................................................... 19 
5.10.1 Adverse Events .......................................................................................... 19 
5.10.2 Vital Signs ................................................................................................. 20 
5.10.3 Prior and Concomitant medications............................................................ 20 
5.10.3.1 Non-Opioid Medication .......................................................................... 21 
5.10.3.2 Opioid Medication During Treatment...................................................... 21 
6. 
Interim Analyses .........................................................................................................21 
7. 
Changes from Protocol Specified Analyses..................................................................22 
8. 
References...................................................................................................................22 
9. 
Appendix.....................................................................................................................22 
9.1 Study Flow Chart ..........................................................................................................23 
9.2 Schedule of Assessments...............................................................................................24 
9.3 Sample SAS code for Section 5.5 Prescott’s Test ..........................................................25 
9.4 Sample SAS code for Section 5.6.2 linear regression model. .........................................26 
9.5 Sample SAS code for Sections 5.6.2.1 and 5.7.2 Van Elteren test..................................27 


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 5 of 40
9.6 Important (Major) Protocol Deviations..........................................................................27 
9.7 Data handing conventions for opioid doses (morphine equivalents)...............................28 


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 6 of 40
LIST OF ABBREVIATIONS
Abbreviation or 
special term
Explanation
AE
Adverse event
ANCOVA
Analysis of covariance
ANOVA
Analysis of variance
BFI
Bowel Function Index
ATC
Anatomical-Therapeutic-Chemical
BM
Bowel movement
BMI
Body mass index
BSS
Bristol Stool Scale
CI
Confidence interval
CRF
Case report form
eCRF
Electronic case report form
ECG
Electrocardiogram
FAS
Full analysis set
MedDRA
Medical Dictionary for Regulatory Activities
LS Mean
Least Square Mean
OIC
Opioid-induced constipation
PEG 3350
Polyethylene glycol 3350
PGIC
Patient Global Impression of Change
PP
Per-protocol
PT
Preferred term
SAE
Serious adverse event 
SBM
Spontaneous bowel movement
SD
Standard deviation
SE
Standard error
SOC
System organ class


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 7 of 40
1.
Study Design
This is a prospective, multi-center, randomized, open-label, crossover study in subjects with 
chronic non-cancer pain to evaluate patients’ preference for opioid-induced constipation (OIC) 
treatment (Movantik™ versus polyethylene glycol 3350 [PEG 3350]), and the reason for their 
preference. After a 1-week washout period, subjects will be randomized to one of two treatment 
sequences (either Movantik first and PEG 3350 second, or PEG 3350 first and Movantik second). 
The subject will then enter the first 2-week treatment period with study medication 1, followed 
by a second 1-week washout period, and then a second 2-week treatment period with study 
medication 2. Subject preference for study medication will be assessed at the end of treatment 
period 2.
The study plans to randomize approximately 256 total subjects, with 128 subjects per treatment 
sequence arm, for a non-completion rate of 20% for approximately 102 completed subjects per 
treatment sequence arm. The subjects were to be recruited and enrolled at approximately 80 sites 
in the United States. Due to rapid enrollment of subjects, the total number of sites that enrolled
subjects was reduced from the target of 80 planned sites to 59 actual sites.
Study design and study scheduled assessments are included in Appendix sections 9.1 and 9.2,
respectively.
2.
Objectives
Primary Objective
x
The primary objective is to determine the preferred treatment for managing OIC 
(Movantik versus PEG 3350) among subjects with chronic non-cancer pain.
Secondary Objectives
x
To assess the reason(s) for patient preference of Movantik or PEG 3350 (only among 
subjects who indicate a preference).
x
To compare the impact of Movantik and PEG 3350 on OIC symptoms.
Safety Objective
x
To examine the safety of Movantik and PEG 3350 for treatment of OIC.
Exploratory Objective
x
To examine the effect of Movantik and PEG 3350 on Bowel Movement 
(BM)/Spontaneous Bowel Movement (SBM) frequency and stool consistency.


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 8 of 40
3.
Analysis Sets
3.1.
Definition of analysis sets
3.1.1 Randomized Set
All subjects who were randomized at Visit 2 are included in the randomized set.
3.1.2 Full Analysis Set (FAS)
All subjects who satisfy inclusion and exclusion criteria, receive study medication, and attend at 
least one scheduled visit will be evaluated in the FAS. Data will be summarized according to the 
randomized treatment sequence (regardless of actual treatment sequence received). The analysis 
set for all but one secondary analyses and all exploratory analyses will be the FAS, unless 
otherwise indicated.
3.1.3 Per-protocol (PP) analysis set
The PP analysis set consists of the subset of FAS subjects who complete the patient preference 
assessment at Visit 5 (end of study), complete the treatment sequence in the order specified by 
the randomized treatment sequence, and are not excluded due to an important protocol deviation 
are included in the PP analysis set. The analysis set for the primary analysis and the secondary 
analysis of reason for preference will be the PP set. 
3.1.4 Safety analysis set
There will be two safety analysis sets – the Pre-Treatment safety analysis set and the Treatment-
Emergent safety analysis set. The Pre-Treatment safety analysis set will include all subjects who 
consent to participate in the study and will be used to list the occurrence of adverse events (AEs) 
prior to exposure to the study medications.
The Treatment-Emergent safety analysis set will include all subjects exposed to at least one dose 
of either study medication. For Treatment-Emergent safety analyses, subjects (including those 
who took the incorrect study treatment) will be summarized according to the actual treatment 
received during each study period. Each AE is also coded by the investigator according to its 
relationship (yes/no) to study medication (Movantik or PEG 3350) and/or rescue medication 
(bisacodyl). 
The Treatment-Emergent safety analysis set will be used for AEs occurring after exposure to 
study medication, as well as for vital signs. Any treatment emergent AE that occurs from Visit 
2 up to (but not including) Visit 4 (including washout period 2) will be summarized according 
to the actual treatment received in treatment period 1. Any treatment emergent AE that occurs 
from Visit 4 onward will be summarized according to the actual treatment received in treatment 
period 2.


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 9 of 40
4.
Outcomes
4.1
Primary – Preference for OIC Treatment
The primary outcome will be the proportion of subjects in each preference category including: 
Prefer Movantik, No Preference, and Prefer PEG 3350. These three categories will be formed by 
collapsing the 7-point rating scale as follows: Prefer Movantik (includes Strong Preference for 
Movantik, Moderate preference for Movantik, Slight Preference for Movantik), No preference, 
and Prefer PEG 3350 (includes Strong Preference for PEG 3350, Moderate preference for PEG 
3350, Slight Preference for PEG 3350).
4.2
Secondary
4.2.1 Reason for Preference
The influence of five medication characteristics (efficacy, tolerability, convenience, works 
quickly, and works predictably) on overall preference (Prefer Movantik, Prefer PEG 3350) as 
outlined, will be rated by the subject using a 4-point rating scale. The influence response levels
include: 0 = No Influence, 1 = Mildly Influenced, 2 = Moderately Influenced, and 3 = Strongly 
Influenced. The reason for preference will only be completed by subjects who indicate a 
treatment preference at Visit 5.
4.2.2 Impact of Movantik and PEG 3350 on OIC symptoms
4.2.2.1 Bowel Function Index (BFI)
The impact of Movantik and PEG 3350 on OIC symptoms will be assessed using the BFI scores 
assessed at the end of each treatment period (Visits 3 and 5). The three items that comprise the 
BFI scale are: Ease of Defecation, Feeling of Incomplete Evacuation, and Personal Judgment of 
Constipation, with each item rated on a scale of 0 to 100. The overall BFI score will be computed 
as the mean of the three individual scale items. The overall score will be set to missing, if at least 
one of the three BFI item scores is missing. The BFI scores are obtained at each scheduled study 
visit, including Screening (Visit 1), the start of each treatment period (Visits 2 and 4), and the 
end of each treatment period (Visits 3 and 5). 
4.2.2.2 Patient Global Impression of Change (PGIC)
The PGIC is completed once at the end of each treatment period (Visits 3 and 5), and measures 
a subject’s global impression of change in OIC symptoms from the start of treatment on a 7-
point scale. The response levels of the PGIC include: 1 = No change, 2 = Almost the same, 3 = 
A little better, 4 = Somewhat better, 5 = Moderately better, 6 = Better and a definite 
improvement, and 7 = A great deal better.  
4.3
Exploratory
4.3.1 BM/SBM frequency
BM frequency will be summarized using information from the subject-completed daily diary.
An SBM is defined as a BM that occurred without the use of rescue laxatives (bisacodyl) in the 
previous 24 hours. 


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 10 of 40
4.3.2 Straining sensation
Straining sensation will be summarized using information from the subject-completed daily 
diary. Subjects will report straining sensation for each BM using a 5-point straining scale,
ranging from 1 = Not at all, 2 = A little bit, 3 = A moderate amount, 4 = A great deal, and 5 = 
An extreme amount.
4.3.3 Bristol Stool Scale (BSS) 
Stool consistency information will be summarized using information from the subject-completed 
daily diary. Subjects will provide a BSS score for each BM. The BSS is a 7-point scale measuring 
stool consistency (see Appendix B of the Clinical Study Protocol).
4.3.4 Rescue Medication
Usage of rescue medication for each treatment will be summarized using information from the 
subject-completed daily diary. Subjects will indicate the date and time that rescue medication 
was used, as well as the number of tablets taken.
4.4
Safety
4.4.1 Adverse Events
To compare the safety of Movantik and PEG 3350, descriptive analyses of AEs and serious 
adverse events (SAEs) will be presented for each treatment. The definition of AEs and SAEs is 
specified in Protocol sections 6.1 and 6.2.
4.4.2 Vital Signs
Vital signs (pulse, blood pressure, and respiratory rate) will be obtained at each scheduled study 
visit (Screening Visit 1, the start of each treatment period on Visits 2 and 4, and the end of each 
treatment period at Visits 3 and 5).
4.4.3 Opioid Medication
Opioid doses will be recorded for each subject, including both the maintenance dose and any 
breakthrough dose which results in a change in dose recorded on the eCRF. The daily opioid 
dose in morphine equivalents (mg/day) will be calculated using the equivalence information in 
Table 1 below (details provided in Appendix section 9.7).
Table 1 
Dose Equivalents for Opioid Analgesics
Oral Dose (mg)
Analgesic
Parenteral Dose (mg)
Oral Morphine 
Equivalents (mg)
15
Morphine
5
15
100
Codeinea
60
15
-
Fentanylb
0.1 (intravenous)
15
10
Hydrocodone
-
15
4
Hydromorphone
1.5
15
2
Levorphanol
1
15
150
Merperidine
50
15


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 11 of 40
10
Oxycodone
-
15
5
Oxymorphone
1
15
100
Propoxyphene
-
15
60
Tapentadol
-
15
67.5
Tramadol
-
15
Note: All doses listed in the above chart will be regarded as equianalgesic. For example, 10 mg of oral
hydrocodone corresponds to 15 mg of oral morphine equivalents. And one mg of parenteral oxymorphone is
considered to be equivalent to 15 mg of oral morphine.
a    Dihydrocodeine is considered equipotent with codeine.
b    )RUWKHKUIHQWDQ\OSDWFKȝJKUWKHequianalgesic daily dose of oral morphine will be considered to
be 15 mg every 4 hh OR 45 mg BID of MS-Contin (i.e., 90 mg/day of morphine). For transmucosal
IHQWDQ\OLHWKHIHQWDQ\O³OROOLSRS´DQȝJGRVHZLOOEHUHJDUGHGDVHTXLYDOHQWWR 30 mg of oral
morphine.
In order to calculate the duration of current opioid use partial start dates will be imputed. If only 
the year is available and the year is prior to 2017, the imputed start date will be 30-June-Year. If 
only the year and month is available and the year is prior to 2017, the imputed start date will be 
15-Month of the corresponding year. If only the year is available and the year is 2017, the 
imputed start date will be 1. January 2017. 
4.4.4 Study Medication Overdose
Information for any study medication overdose will be summarized in a listing which includes 
treatment sequence, medication, site, subject number, age, sex, start and stop date, intentional 
overdose (yes/no), form of medication, route, dose, total daily dose, dose unit, and any AE 
associated with overdose (yes/no). 
5.
Analysis Methods
5.1 General Principles
Unless otherwise indicated, descriptive statistics for categorical variables will include counts and 
percentages, and descriptive statistics for continuous variables will be presented as number of 
subjects (n), mean, standard deviation (SD), median, minimum, and maximum. For continuous 
variables, the mean and median will be reported to one more decimal place than the recorded 
value, the standard deviation (and standard error for LS Means) will be reported to two more 
decimal places than the recorded value, and the minimum and maximum will be reported to the 
same number of decimal places as the recorded value. For categorical variables, the percentage 
of subjects will be reported to one decimal place.  P-values will be reported to 4 decimal places.
Summary tables will be presented by treatment, or by treatment sequence, where appropriate. In 
general, tables of baseline variables (e.g. subject disposition, demographics, prior medications
including prior opioids, and medical history) will be presented by treatment sequence. Summary 
tables for the primary, secondary, exploratory and safety outcomes will be presented by 
treatment (Movantik and PEG 3350), both overall and by treatment sequence. For this crossover 
study, the overall summary will present results for each treatment for both time periods, whereas 
the summary by treatment sequence will present results by order of treatment presentation. In 
addition to summary tables, subject listings will be produced for all data collected for the study, 
and all summary tables will be cross listed with corresponding listings.


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 12 of 40
As stated in Section 4.4.3, in order to calculate the duration of current opioid use, partial start 
dates will be imputed. No other imputation will be performed for missing data, and all analyses 
will be performed on observed cases. The p-values for all secondary and exploratory measures 
will be considered descriptive only. All p-values are two-sided.
5.2 Subject Disposition
A summary table of subject disposition of all enrolled subjects (by treatment sequence and 
overall) will be presented for the number and percentage of subjects enrolled, screen failures, 
randomized, randomized and treated, completed Movantik, completed PEG 3350, completed 
period 1, completed period 2, completed both periods, and discontinued (with reasons for 
discontinuation). A summary table will also be presented for the number and percentage of FAS 
subjects by investigator (by treatment sequence and overall). In addition, a summary table of all 
enrolled subjects with important protocol deviations will be presented (by treatment sequence 
and overall) for categories listed below in Section 5.3. A separate table will also summarize the 
number and percentage of screen failures and all enrolled subjects in each analysis set (by 
treatment sequence and overall).
Listings related to subject disposition include: treatment assignment for each subject (including 
site, subject number, randomized treatment sequence, actual treatment sequence, informed 
consent date and randomization date, dates for visits 3,4 and 5, study completion status, and date 
of study completion); subjects discontinued from the study
(including randomized
treatment/treatment sequence, site, subject number, actual treatment, reason for discontinuation, 
date of last study medication, date discontinued/date of death, study day discontinued); study 
medication for each subject (including treatment sequence, site, subject number, age, sex, date 
medication taken, study day, whether study medication was entered in diary for each study day
[yes/no], time taken, study medication taken, which study medication taken); subjects with 
protocol deviations (including treatment sequence, site, subject number, age, sex, race, treatment,
protocol deviation date, visit, study day, protocol deviation, importance); screen failures
(including site, subject number, age, sex, reason for screen failure, informed consent date, and 
discontinuation date); and randomization, evaluability and demographic data for all enrolled 
subjects (including treatment sequence, site, subject number, age, sex, ethnicity, race, and 
inclusion [yes/no] in each of the analysis sets of randomized subjects, FAS, PP, treatment-
emergent safety, and pre-treatment safety).
5.3 Protocol Deviations
Protocol deviations are deemed important if they have the potential to influence the assessments 
of the true treatment effect. All protocol deviations will be listed and tabulated. The following 
important (major) protocol deviations are described in detail in Appendix section 9.6.
x
Randomized but did not meet requirements for randomization
x
Took prohibited laxative during the study period
x
Took prohibited opioid antagonists and mixed agonists/antagonists during the study 
period
x
Reason for discontinuation indicated as “Non-compliance with study drug” or 
“Protocol deviation” on the disposition form
x
Randomized but not treated (did not receive any study medication)


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 13 of 40
x
Errors in randomizations and treatment dispensing. An error in randomization is when 
a subject is not randomized or treated according to the treatment sequence schedule. It 
is envisaged there may be two sub-categories of this:
íSubjects who receive no treatment whatsoever for a period of time due to errors 
in the dispensing of medication. Note, this is not due to tolerability issues where 
subjects may stop taking the drug.
í7KHsubject receives an incorrect study medication according to the treatment 
sequence specified in the randomization code.
The important protocol deviations will be reviewed and documented by the medical advisors and 
statisticians prior to database lock to help identify subjects to be excluded from the PP analysis 
set. 
5.4 Subject Demographics and Baseline Characteristics
A subject demographics table will include age, age group (e.g. <50, 50 to <64, 65 years), sex,
ethnicity, and race, by treatment sequence and overall. A summary table of baseline 
characteristics will include height, weight, body mass index (BMI), any abnormal physical exam 
results (yes/no), prior use of either Movantik or PEG 3350 within 1 year prior to the study, prior 
use of any laxatives within 2 weeks prior to the screen visit (with categories of: Any [at least 1 
laxative]; Any [2 laxatives]; any laxative other than Movantik or PEG 3350; Movantik; PEG 
3350; Both Movantik and PEG 3350; or Missing), pain scale (using number and percentage of 
subjects in each category, and n, mean, SD, median, minimum and maximum as continuous 
measures), duration of current opioid use in months, and morphine-equivalent opioid dose at 
screening (see Section 4.4.3 for conversion of reported opioid dose to morphine equivalents). A
summary table will also be presented for prior medical history, with the number and percentage 
of subjects with and without any medical history, as well as the number and percentage of 
subjects by System Organ Class (SOC) and Preferred Term (PT). Tables will also be provided 
for prior medications (excluding opioids), as well as for prior opioid medications, with the 
number and percentage of subjects with any prior medications, as well as the number and 
percentage of subjects classified by Anatomical-Therapeutic-Chemical (ATC) code and PT.
Further detail on prior medications is provided in Section 5.10.2.
Listings related to subject demographics and baseline characteristics are: baseline characteristics 
(including treatment sequence, site, subject number, age, sex, ECG reviewed, ECG type, ECG 
clinically significant, lab reviewed, lab type, lab clinically significant, any prior Movantik or 
PEG 3350 use [Movantik only, PEG 3350 Only, Both], pain scale, reason for pain, overall BFI 
score and individual BFI component scores at visits 1 and 2); physical exam (including treatment 
sequence, site, subject number, age, sex, height, weight, BMI, visit, date, general appearance, 
abdomen assessed, respiratory assessed, cardiovascular assessed); prior medications excluding
opioids (including treatment sequence, site, subject number, age, sex, ATC, PT, investigator 
term, start and stop dates, duration, dose/unit, frequency, route and indication); prior opioid 
medications (including treatment sequence, site, subject number, age, sex, ATC, PT, investigator 
term, start and stop dates, duration, dose/unit, frequency, morphine-equivalent dose, route and 
indication); prior laxatives (including treatment sequence, site, subject number, age, sex.
Movantik or PEG 3350 taken 1 year prior [yes/no], medication taken, stop dose, duration taken, 
duration unit, any prior laxative in last 2 weeks [yes/no], medication. Dose form, route, dose, 
total daily dose, dose unit, frequency, start and stop dates, ongoing [yes/no]); and medical history


Statistical Analysis Plan 
Study Code D3820L00017
Version Number 1.0
Date 15 August 2017
Page 14 of 40
(including treatment sequence, site, subject number, age, sex, SOC, PT, medical history term, 
start and stop dates, ongoing, controlled with mediation, any current medication for medical 
condition).
All baseline tables will be presented by treatment sequence and overall for the FAS.
5.5 Exposure and Compliance
A subject exposure table using the FAS will summarize the number of days subjects were 
exposed to each treatment medication, overall and by treatment sequence (including: n, mean, 
SD, median, minimum and maximum). Exposure for each treatment is calculated as the number 
of days from first dose date in case report form (CRF) start (Visits 2/4) to last dose date in CRF 
(Visits 3/5). In addition, a cumulative exposure table will tabulate the total number and 
percentage of subjects completing each week of the study by treatment, overall and by treatment 
sequence.
A compliance table using the FAS will summarize subjects’ compliance to study medication by 
treatment and timepoint (treatment week 1, treatment week 2, and treatment weeks 1 and 2),
overall and by treatment sequence. Study medication compliance is defined as the sum of the 
number of doses of study medication actually taken (as recorded in the subjects daily diary),
divided by the number of theoretically due doses, multiplied by 100. The number of theoretically 
due doses is computed as the number of days from the start of treatment (Visits 2/4) to the last 
day of each treatment period.
5.6 Primary Analyses
5.6.1 Preference for OIC Treatment
The primary analysis will aim to determine the proportion of subjects in the PP analysis set in 
each preference category including: Prefer Movantik, No Preference, and Prefer PEG 3350. The 
three categories are collapsed from the 7-point preference scale (as described in Section 4.1).
The analysis for the primary outcome of patient’s preference (Prefer Movantik, No Preference, 
Prefer PEG 3350) will use Prescott’s test to assess the difference in preference for the two 
treatments (Prescott, 1981; Senn 2002). Prescott’s test analyzes the difference between the 2 
treatment sequences in a 2 (treatment sequence AB, treatment sequence BA) by 3 (Prefer First 
Treatment Received, No Preference, Prefer Second Treatment Received) contingency table. The 
cell counts in the contingency table follow a hypergeometric probability distribution, and 
Prescott’s test assesses the probability of obtaining a table with cell counts of equal or more 
extreme values. Prescott’s test is only applicable for subjects who complete the entire treatment 
sequence, i.e., subjects in the PP analysis set. Prescott’s test is computed as an exact 2-sided p-
value. The SAS pseudo code for this analysis is presented in Appendix section 9.3.
There is only a single primary outcome variable at the end of the study; thus no adjustment for 
multiplicity is needed.
A summary table of the counts and percentages of subjects’ preference for OIC treatment will 
be presented. A detailed summary table, by treatment sequence, will also present the number and 
percentage of subjects in each of the seven categories of subject preference (Strong preference 
for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No 
preference, Slight preference for PEG 3350, Moderate preference for PEG 3350, Strong 


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preference for PEG 3350), as well as subjects’ preference for Period 1 treatment, no preference, 
and preference for Period 2 treatment, and include the p-value from Prescott’s test. An additional
table will summarize subjects’ preference for OIC treatment for specific subgroups, including 
laxative use in 2 weeks prior to screening, previous use of Movantik or PEG 3350 within 1 year 
SULRUWRVFUHHQLQJDJHJURXSWRDQGFKDQJHLQRSLRLGPHGLFDWLRQIURP
Visit 2 through Visit 5 (decrease, no change, or increase).  Details on subgroups are provided in 
Section 5.9.
A listing of subjects who expressed a treatment preference (including treatment sequence, site, 
subject number, preferred treatment, and reasons for preferred treatment) will be provided.
5.7 Secondary Analyses
5.7.1. Reason for Preference
The subject-reported influence of each medication characteristic on overall preference will be 
summarized for the following characteristics: efficacy, tolerability, convenience, works quickly, 
and works predictably. A summary table will include the counts and percentages of subjects’ 
ratings of the influence of each characteristic (measured on a 4-point scale) by preferred 
treatment. The influence score levels range from 0 = No Influence, 1 = Mildly Influenced, 2 = 
Moderately Influenced, and 3 = Strongly Influenced. In addition, a table of descriptive statistics 
(n, mean, SD, median, minimum, and maximum) will summarize the influence category scores 
for each medication characteristic by preferred treatment (overall and by treatment sequence).
The analysis population will be the PP set.
5.7.2 Impact of Movantik and PEG 3350 on OIC symptoms
For analyses of secondary continuous variables, a linear regression model with terms for 
intercept, treatment (Movantik, PEG 3350, period (Period 1, Period 2), sequence (Movantik/PEG
3350, PEG 3350/Movantik) and subject within sequence will be used to assess the direct 
treatment effect as well as any effect of period (Senn, 2002). For the analysis of change scores, 
the baseline score at the start of each treatment period (Visits 2/4) will be included in an analysis 
of covariance (ANCOVA) model.
The mean score for the continuous variable will be tested for nominally significant differences 
between the two treatments by the following analysis of variance (ANOVA) model for cross-
over designs:
Yijkt = μ + SEQj + SUBi(j) + PERk + TRTt + eijkt
Where, 
Yijkt
is the dependent continuous variable, measured at sequence j, for subject i at 
period k receiving treatment t.
μ
is the overall mean,
SEQj
is the sequence fixed effect (j = 1 to 2).
SUBi(j)
is the random effect for subject i nested within sequence j, where SUBi(j) ~ N(0, 
į2s).


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PERk
is the period fixed effect (k = 1 to 2).
TRTt
is the treatment fixed effect (t= 1 to 2).
eijkt
LVWKHUHVLGXDOUDQGRPHUURUZKHUHHa1į2e).
The variation between subjects is assumed to be random. Sequence effects will be tested using 
the between-subjects, within-sequence mean square in the ANOVA model, and period and 
treatment effects will be tested using the error term. The treatment effect will be estimated using
the difference in Least Square (LS) means, its standard error (SE), and the corresponding 95% 
confidence interval (CI). The SAS pseudo code for this analysis is presented in Appendix section 
9.4.
The linear regression crossover model will be used for the following secondary variables:
x
PGIC, using a 7-point scale (ANOVA model).
x
BFI, a numeric analogue scale from 0 to 100, using the mean of 3 variables including:
ease of defecation, feeling of complete evacuation, and personal judgment of 
constipation (ANCOVA model).
5.7.2.1 Patient Global Impression of Change (PGIC)
A table summarizing the number and percentage of subjects in each category of the PGIC by 
treatment (overall and by treatment sequence), and the p-value will be computed using the Van 
Elteren test (where strata is the treatment sequence). The SAS pseudo code for the Van Elteren 
test analysis is presented in Appendix section 9.5.
In addition, a descriptive summary table will be presented (overall and by treatment sequence) 
for the PGIC measured at the end of the treatment period (Visits 3/5), and will include n, mean, 
median, SD, minimum, and maximum by treatment. A table of ANOVA results will also be 
presented, as well as a table of the estimated LS Means, difference in LS Means, SE and 95% CI 
of the difference in LS Means. The analysis population will be the FAS set.
A listing will include treatment sequence, site, subject number, age, sex, treatment, visit, visit 
date, and PGIC score.
5.7.2.2 Bowel Function Index (BFI)
For the BFI, a descriptive statistics summary table including n, mean, median, SD, minimum,
and maximum will be presented for the observed score at screening (Visit 1), baseline (Visits 
2/4), and end of treatment period (Visit 3/5) by treatment, overall and by treatment sequence.
The descriptive statistics summary table will also include change from baseline (from Visits 2/4 
to Visits 3/5). The BFI completed at Visit 2 will serve as the baseline for treatment period 1. The 
BFI completed at Visit 4 will be the baseline for treatment period 2. A table of ANCOVA results 
(including a term for baseline BFI score) will also be presented for the overall BFI score 
(computed as the mean of the 3 non-missing individual BFI measures stated in section 4.2.2.1),
as well as a table of the estimated LS Means, difference in LS Means, SE and 95% CI of the 
difference in LS Means. The analysis population will be the FAS set.


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A listing will include treatment sequence, site, subject number, age, sex, treatment, visit, visit 
date, overall BFI score and each component score (ease of defecation, feeling of incomplete 
evacuation, and personal judgment of constipation).
5.8 Exploratory Analyses
Exploratory outcomes include:
x
BSS, using a 7-point scale of stool consistency measured for each BM;
x
Straining sensation, using a 5-point straining scale reported for each BM;
x
BM frequency;
x
SBM frequency;
x
Usage of rescue medication.
5.8.1 Bristol Stool Scale (BSS)
For each subject, the most frequent BSS category for each treatment and time period (washout 
period prior to each treatment, and treatment period) will be classified. If the most common BSS 
category per time period cannot be determined for a given subject (in case of ties), the subject 
will be classified as “could not be determined”. A summary table will present the number and
percentage of subjects per the most common BSS category for each treatment and time period
(previous washout and treatment period), overall and by treatment sequence.
For each subject, the observed average BSS score will be computed as the mean of all non-
missing BSS scores during a given time period (previous washout and treatment period). A
descriptive statistics summary table for mean stool consistency (with n, mean, median, SD, 
minimum, and maximum) will also be presented by treatment and time period, using the average 
BSS score computed during the washout period prior to each treatment, and the average BSS 
scores during treatment week 1 period, treatment week 2 period, and treatment period for weeks 
1 & 2. The table will be summarized overall, and by treatment sequence. A summary table of 
the average number of BMs for each category of the Bristol Stool Scale and timepoint (previous 
washout and treatment period) will be presented, overall and by treatment sequence.
For the BSS measure, the ANCOVA model described in section 5.7.2 will be used for the 
observed average BSS score computed for each treatment period. A linear regression model with 
terms for subject, baseline BSS score (computed as the average BSS score during the prior 
washout period), treatment sequence (Movantik/PEG 3350 or PEG 3350/Movantik), treatment 
period (Period 1, Period 2), treatment (Movantik, PEG 3350), and subject within treatment will 
be used to assess the direct treatment effect as well as any effect of the period. The average BSS 
score computed for the first washout period will be the baseline for treatment period 1, and the
average BSS score computed for the second washout period will be the baseline for treatment 
period 2. A table of ANCOVA results will be presented for the average BSS score, as well as a
table of the estimated LS Means, difference in LS Means, SE and 95% CI of the difference in 
LS Means. The analysis population will be the FAS set.


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A listing will include treatment sequence, site, subject number, age, sex, treatment, date/study 
date/time of each BM, spontaneous BM [yes/no], and straining score.
5.8.2 Straining Sensation 
For each subject, the most frequent straining scale category for each treatment and time period 
(washout period prior to each treatment, and treatment period) will be classified. If the most 
common straining scale category per time period cannot be determined for a given subject, the 
subject will be classified as “could not be determined”. A summary table will present the number 
and percentage of subjects per straining scale category by treatment and time period (previous 
washout and treatment period), overall and by treatment sequence, and the p-value will be 
computed using the Van Elteren test (where strata is the treatment sequence).
For each subject, the observed average straining scale score will be computed as the mean of all 
non-missing straining scale scores during a given time period. A descriptive statistics summary 
table of the mean degree of straining (with n, mean, median, SD, minimum, and maximum) will 
be presented by treatment and time period, using the average straining scale score computed 
during the washout period prior to each treatment, and the average straining scale score during 
treatment week 1, treatment week 2, and treatment weeks 1 & 2. The table will be summarized 
overall, and by treatment sequence.
A summary table of the average number of BMs for each category of the straining scale and 
timepoint (previous washout and treatment period) will be presented, overall and by treatment 
sequence.
For the straining scale measure, the ANCOVA model described in Section 5.7.2 will be used for 
the observed average straining score computed for each treatment period. A linear regression 
model with terms for subject, baseline straining scale score (computed as the average straining 
scale score during the prior washout period), treatment sequence (Movantik/PEG 3350, PEG 
3350/Movantik), treatment period (Period 1, Period 2), and treatment (Movantik, PEG 3350), 
will be used to assess the direct treatment effect as well as any effect of period. The average 
straining scale score during the first washout period will be the baseline for treatment period 1. 
The average straining scale score during the second washout period will be the baseline for 
treatment period 2. A table of ANCOVA results will be presented, as well as a table of the 
estimated LS Means, difference in LS Means, SE and 95% CI of the difference in LS Means.
The analysis population will be the FAS set.
5.8.3 BM/SBM Frequency
The average number of BMs per week is computed for each subject as the total number of BMs 
divided by the total number of days the subject was in the time period, times 7. A table will 
summarize the BM average for each time period (washout, treatment week 1, treatment week 2, 
and treatment weeks 1 and 2) by treatment, overall and by treatment sequence. A similar table 
will be presented for SBMs. The analysis population will be the FAS set.
5.8.4 Rescue Medication
Usage of rescue medication by treatment will be summarized by the number of times (and 
percentage) that rescue medication was used per subject (none, 1 time, 2 times, 3 times, 4 times
for each time point including washout prior to treatment, treatment week 1, and treatment week 
2; and QRQHWLPHWLPHVWLPHVWLPHVWLPHVWLPHVWLPHVDQGWLPHVIRUtreatment 


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weeks 1 and 2 combined), overall and by treatment sequence. The table will also summarize the 
mean bisacodyl use, defined as the sum of the bisacodyl dose (number of tablets x 5 mg per 
tablet) from each time period, divided by the number of days in the time period where the subject
recorded diary data, multiplied by 7. The analysis population will be the FAS set.
5.9 Subgroups
A summary table of the counts and percentages of subjects’ preference for OIC treatment in 
Section 5.7.1 will be presented for each of the following subgroups:
x
Prior history of laxative use 2 weeks prior to screening (Any laxative use, No laxative 
use, Previous Movantik use, Previous PEG 3350 use)
x
Previous Movantik and/or PEG 3350 use within 1 year prior to screening (Movantik 
only, PEG 3350 Only, Both, None)
x
$JHJURXSWR\HDUV
x
Change in opioid medication from Visit 2 to Visit 5 (Increase, No change, Decrease)
The analysis population will be the PP set.
5.10 Safety
Safety outcomes include AEs, SAEs, vital signs, and concomitant medications.
5.10.1 Adverse Events
AEs and SAEs will be coded by SOC and PT using the Medical Dictionary for Regulatory 
Activities (MedDRA) version 19.1. All summary tables will use the Treatment-Emergent Safety 
set. A listing will be provided for all Pre-Treatment AEs. All AEs will be tabulated according to 
the last treatment received prior to or at the time of onset. The actual treatment taken will be used 
for all AE summary tables (for any subject who may have received the incorrect study drug 
according to the randomized treatment sequence).
A general summary table will present the number and percentage of subjects with any AE, any 
treatment-related AE, any serious AEs, deaths, and any subjects with AEs leading to study drug 
discontinuation by treatment. 
A summary table will also be presented for all AEs by SOC and PT. The table will summarize 
the number and percentage of subjects and the number of events, for any AE, as well as AEs
classified by SOC and PT. If a subject has multiple occurrences of an AE, the subject is presented 
only once in the respective subject count column for the corresponding AE. Events are counted 
each time in the event column.
A similar table will summarize the incidence of AEs by SOC and PT, according to maximum 
intensity. If a subject has multiple occurrences of an AE, the subject is presented only once at 
the maximum intensity in the respective subject count column for the corresponding AE, whereas 
events are counted each time in the event column. Events with missing intensity are counted as 
severe. 


Statistical Analysis Plan 
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A summary table will also be presented for the incidence of AEs by SOC and PT by relationship 
to treatment. Each AE is coded by the investigator according to its relationship to study treatment 
(either Movantik or PEG 3350, depending on study period) and/or rescue medication (bisacodyl). 
Each AE will be summarized according to one of the following mutually exclusive relationship 
categories (Related to treatment only, Related to bisacodyl only, Related to treatment and 
bisacodyl, Not related). Within each SOC and PT, a given subject can appear in multiple 
relationship categories. If a subject has multiple occurrences of an AE, the subject is presented 
only once in the respective subject count column for the corresponding AE, whereas events are 
counted each time in the event column. Events with a missing relationship are counted as related
to study treatment (according to the last treatment received prior to or at the time of onset).
Separate summary tables will present the incidence of AEs by SOC and PT for events leading to 
study drug discontinuation, and for AE leading to study discontinuation. An additional table of 
key information for AEs leading to study drug discontinuation will include treatment sequence, 
subject number, actual treatment received, age, sex, investigator term, PT, number of days from 
start of treatment to onset of AE, number of days from start of treatment to discontinuation, 
serious AE (yes/no), outcome, and reasonable possibility that AE was caused by study drug (at 
least possibly related).
A table will also summarize the incidence of all serious AEs by SOC and PT. An additional table 
of key information for serious AEs will also be presented, which will include treatment sequence,
subject number, actual treatment received, age, sex, investigator term, PT, number of days from 
start of treatment to onset of AE, number of days from last dose to onset of AE, number of days 
from start of treatment to AE becoming serious, outcome, and reasonable possibility that AE was 
caused by study drug (at least possibly related).
A listing of all AEs will include treatment sequence, site, age, sex, treatment at onset,
SOC/PT/AE description, start and stop dates, onset day, onset period, duration, outcome, severity
(or intensity), relationship to study medication(s), and action taken. A similar listing will be 
presented for SAEs, deaths, or other clinically significant AEs.
5.10.2 Vital Signs
A descriptive statistics summary table for vital signs (blood pressure, pulse and respiration rate) 
will also be presented with n, mean, median, SD, minimum, and maximum at each time point by 
treatment, overall and by treatment sequence. The table will also include change from baseline 
(Day 1 of each treatment period on Visits 2/4) to end of treatment period (Visits 3/5). Summary 
results will be based on the Treatment-Emergent Safety set. A listing of vital signs will include 
treatment sequence, site, subject number, age, sex, actual treatment, visit, visit date, systolic and 
diastolic blood pressure, pulse, and respiration rate,
5.10.3 Prior and Concomitant medications
All medications collected will be coded to ATC classification and PT using WHO drug version 
September 2016. A prior medication is defined as any medication taken by the subjects within 
60 days prior to the screening visit (V1) and discontinued before the randomization visit (V2). 
A concomitant medication is defined as a medication that is ongoing at the randomization visit 
(V2), or a medication that starts on or after the randomization visit (V2).


Statistical Analysis Plan 
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5.10.3.1 Non-Opioid Medication
A summary table will be presented for concomitant medications (excluding opioids and 
prohibited medications), with the number and percentage of subjects with and without any 
concomitant medications, as well as the number and percentage of subjects with medications
classified by ATC classification and PT. All concomitant medication tables will be presented by 
treatment and overall for the FAS.
A summary table of any prohibited/restricted medications (as defined by medical advisers) taken 
during the treatment and washout periods only, will be presented. The tables will summarize the 
number and percentage of subjects with prohibited medications by ATC and PT.
A listing of all concomitant medications (excluding opioids) will be provided, including 
treatment sequence, site, subject number, subject age and sex, ATC and PT classification, 
investigator term, start and stop dates, ongoing (yes/no), dose/unit, frequency, route and 
indication.
In addition, a listing of any overdose in study medication (bisacodyl, Movantik or PEG 3350) 
will include treatment sequence, treatment, site, subject number, age, sex, start and stop dates, 
intentional overdose [yes/no], form of medication, route, total daily dose, and any AE associated 
with overdose [yes/no].
5.10.3.2 Opioid Medication During Treatment
Opioid medication and doses will be recorded for each subject at screening and during the study,
including both the maintenance dose and any change in dose recorded on the eCRF, and the daily 
opioid dose in morphine equivalents (mg/day) will be calculated using the equivalence 
information in Table 1 (Section 4.4.3).
Daily opioid dose is computed as the sum of the morphine-equivalent dose for all opioid 
medications per day per subject (including the maintenance dose and any breakthrough opioid
dose). The mean daily opioid dose (mg/day) for an interval will be calculated as the sum of daily 
opioid doses (mg/day) for the interval divided by the number of days within the interval in which 
the data were collected. Change from baseline in mean daily opioid dose will be calculated for 
each day of the study period, computed as the post-baseline value minus the baseline value, 
where baseline is the daily opioid dose recorded at Visit 2. Positive changes from baseline 
indicate an increase in opioid dose. A table will summarize the number of subjects with any 
decrease in opioid dose, no change in dose, or any increase in dose post baseline during the 
treatment phase from Visit 2 though Visit 5. If a subject has both an increase and a decrease
during the treatment phase, an increase will be used. In addition, the table will summarize the 
number and percentage of subjects who have any decreasHLQGDLO\RSLRLGGRVHRIDQGWKH
number and percentage of subjects who have any increase in daily opioid dose RI
A table will also be presented for all concomitant opioid medications classified by ATC and PT.
A listing of all concomitant opioid medications will be provided, including treatment sequence, 
site, subject number, subject age and sex, ATC and PT classification, investigator term, start and 
stop dates, visit, dose change from baseline, ongoing (yes/no), dose/unit, oral morphine-
equivalent, frequency, route and indication.
6.
Interim Analyses 


Statistical Analysis Plan 
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No interim analyses are planned.
7.
Changes from Protocol Specified Analyses
This statistical analysis plan specifies that the comparison of treatment groups for PGIC should 
use the Van Elteren test (Stokes, 1995) in addition to the ANOVA specified in the protocol.
The protocol originally stated that Wilcoxon signed rank test would be used for the straining 
scale analysis. This was revised to use Van Elteren test for both PGIC and straining scale 
measures to provide test of difference between the treatments.
8.
References
Senn, S, Cross-over Trials in Clinical Trial Research, Second Edition, 2002
Prescott, R.J. (1981) The comparison of success rates in cross-over trials in the presence of an 
order effect, Applied Statistics, Vol. 30, 9-15. 
Stokes, M.E., Davis, C.S., Koch, G.G. (1995) Categorical Data Analysis Using the SAS 
System, Cary, NC: SAS Institute.
Feng, W. W., Ding, D. (2014) Paper SP02 SAS@ Application In 2 * 2 Crossover Clinical
Trial, Cary, NC: SAS Institute.
9.
Appendix


Statistical Analysis Plan 
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9.1 Study Flow Chart
         BFI = Bowel Function Index; PGIC = Patient Global Index of Change; V1 – V5 = Visit1 – Visit 5




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9.3 Sample SAS code for Section 5.5 Prescott’s Test 
*data from Feng and Ding;
data fishers;
input seq pref count;
cards;
1 1 7
1 2 11
1 3 2
2 1 2
2 2 10
2 3 8
;
run;
title4 'fishers';
proc print data=fishers;
run;
data fishers2;
set fishers;
do i = 1 to count;
sequence = seq;
preference = pref;
outcome = 1;
output;
end;
run;
proc freq data=fishers2;
tables sequence*preference / fisher exact norow nocol nopercent ;
run;


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9.4 Sample SAS code for Section 5.6.2 linear regression model.
data ab;
input obs subject $ month treatment sequence $ outcome; 
cards;
1
CK
1 0 AW 6
2
CK
2 1 AW 6
3
DH
2 0 WA 10
4
DH
1 1 WA 8
5
DP
1 0 AW 24
6
DP
2 1 AW 16
7
DS
2 0 WA 20
8
DS
1 1 WA 16
9
DS2 2 0 WA 14
10 DS2 1 1 WA 16
11 EM 1 0 AW 14
12 EM 2 1 AW 16
;
run;
data ab2;
set ab;
trt=treatment;
seq = sequence;
period = month;
DV = outcome;
patient=subject;
run;
title4 'Crossover Proc Mixed';
proc mixed data=ab2 covtest;
class SEQ PATIENT PERIOD TRT  ;
model DV = TRT PERIOD SEQ
/ solution ddfm=kenwardroger; ***recommended for crossover;
random intercept / subject = PATIENT v vcorr  ;
lsmeans TRT / pdiff cl;
run;


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9.5 Sample SAS code for Sections 5.6.2.1 and 5.7.2 Van Elteren 
test.
**********************************************;
data ab;
input obs subject $  treatment sequence $ outcome; 
cards;
1  CK   0 AW 4
2  CK   1 AW 6
3  DH   0 WA 5
4  DH   1 WA 7
5  DP   0 AW 1
6  DP   1 AW 2
7  DS   0 WA 3
8  DS   1 WA 3
9  DS2  0 WA 4
10 DS2  1 WA 7
11 EM   0 AW 1
12 EM   1 AW 4
;
run;
proc freq data=ab;
table sequence*treatment*outcome / cmh scores=modridit noprint;
run;
9.6 Important (Major) Protocol Deviations  
The important (major) protocol deviations will be the following:
x
Randomized but did not meet requirements for randomization.
-
&RQILUPHG2,&E\%),DW9LVLWDQG9LVLW
-
Receiving a stable maintenance opioid regimen consisting of a total daily dose of at 
least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies for a 
minimum of 1 month with stable dosing for at least 2 weeks prior to screening for 
non-cancer related pain with no anticipated change in opioid dose requirement over 
the proposed study period as a results of disease progression. The opioid regiment 
should be confirmed by a prescription or clearly labeled medication bottle.
x
Took prohibited laxative during the study period.
All medications for each subject will be reviewed to determine if any prohibited laxatives
were taken after the start of study drug and prior to the follow-up period. The list of
prohibited laxatives other than bisacodyl includes the following: milk of magnesia or 
magnesium citrate, non-absorbable phosphate, cascara, senna, castor oil/mineral oil, 
epsom salt, lactulose, docusate, enemas, tegaserod, lubiprostone (Amitiza®), drugs 
blocking fat absorption with an associated laxative effect, Prucalopride, prune juice, 
herbal preparations for constipation, bulk laxatives, such as psyllium and 


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methylcellulose. Other prohibited laxatives include any agent that is used in an off-label 
fashion to treat constipation (e.g., colchicine, misoprostol, erythromycin, cholinesterase 
inhibitors such as donezepil), and any experimental constipation therapy.
x
Took prohibited opioid antagonists and mixed agonists/antagonists during the study 
period.
All medications for a subject will be reviewed by the study physician before database 
lock to determine if any prohibited opioid antagonists and mixed agonists/antagonists 
were taken after the start of study drug which might have a significant impact on efficacy. 
The list of prohibited opioid antagonists and mixed agonists/antagonists includes the 
following: concomitantly using strong (e.g., ketoconazole, itraconazole, clarithromycin) 
or moderate (e.g., diltiazem, erythromycin, verapamil) CYP3A4 inhibitors and strong 
CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort), methadone or 
buprenorphine or other opioid antagonists.
x
Reason for discontinuation indicated as “Non-compliance with study drug” or “Protocol 
deviation” on the disposition form.
Subjects who discontinue the study for whom “Non-compliance with study drug” is 
indicated on the disposition form will be included in this category, as well as subjects 
with “Protocol deviation” indicated on the disposition form who have documented non-
compliance with study medication.
x
Randomized but not treated (did not receive any study medication).
x
Errors in randomization or treatment dispensing. An error in randomization occurs when 
a subject is not randomized or treated according to the treatment sequence schedule 
specified in the randomization code. It is envisaged there may be two sub-categories of 
this:

-
Subjects who receive no treatment whatsoever for a period of time due to errors in 
dispensing of medication. Note, this is not due to tolerability issues where subjects
may stop taking drug.
-
The subject receives a treatment medication that differs from that associated with 
their treatment sequence randomization code.
9.7 Data handing conventions for opioid doses (morphine 
equivalents)
Reported frequency of administration of opioid dosing will be mapped to the number of daily
doses (example table is presented below). Because dosing frequency can be reported on a free 
text field, the frequency factor will be determined based on a medical review of the data. For
transdermal opioid patches (e.g., fentanyl, buprenorphine), a continuous around-the-clock 
release of the drug substance will be assumed. Daily dose for the transdermal opioids will be


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calculated based on the dose released per hour (i.e., 24 x dose/h). Frequency of 1 will therefore 
be used for the daily dose.
MEDFREQ
Analysis Frequency
ROUTE
1 EVERY 3 DAYS TOPICALLY
1
CUTANEOUS
TID
3
ORAL
1 BID
2
ORAL
1 EVERY 4-6 HOURS
4
ORAL
1 EVERY 4HRS
6
ORAL
1 EVERY 6 HRS
4
ORAL
1 PATCH FOR 72 HOURS
1
CUTANEOUS
1 PATCH Q 72 HOURS
1
CUTANEOUS
1 TAB EVERY 4 HOURS
6
ORAL
1 TABLET 4 TIMES A DAY
4
ORAL
1 TABLET 4 TIMES A DAY FOR PAIN
4
ORAL
1 TABLET BY MOUTH AT BEDTIME
1
ORAL
1 TABLET EVERY 4 HOURS
6
ORAL
1 TABLET EVERY 4 TO 6 HOURS
4
ORAL
1 TABLET EVERY 6 HOURS
4
ORAL
1 TABLET EVERY 6 HOURS FOR PAIN
4
ORAL
1 TABLET QD
1
ORAL
1 TABLET THREE TIMES DAILY
3
ORAL
1 TABLET TID
3
ORAL
1 THREE TIMES A DAY
3
ORAL
1 THREE TIMES DAILY
3
ORAL
1-2 EVERY 4-6 HOURS
4
ORAL
1-2 TABS EVERY 4-6 HOURS
4
ORAL
1-2 TABS EVERY 6-8 HOURS
3
ORAL
1-2 TABS Q 6 HOURS
4
ORAL
1/2 TAB TID
1.5
ORAL
1X
1
INTRAMUSCULAR
1X
1
INTRAVENOUS
2 - 60MG TABS Q A.M. AND 1-60MG TAB Q
P.M.
3
ORAL
2 BID
4
ORAL


Page 30 of 40
MEDFREQ
Analysis Frequency
ROUTE
2 FOUR TIMES DAILY
8
ORAL
2 Q 4-6 HRS
8
ORAL
2 Q3DAYS
2
CUTANEOUS
2 QID
8
ORAL
2 TABLETS EVERY 12 HOURS
4
ORAL
2 TABS BID
4
ORAL
2 TABS EVERY 6 HOURS
8
ORAL
2 TABS Q4HRS
12
ORAL
2 TABS QD
2
ORAL
2 TABS QID
8
ORAL
2 TABS TID
6
ORAL
2 X DAILY 10 MG
2
ORAL
2/DAY
2
ORAL
24 HOUR PATCH/EVERY 3 DAYS
1
CUTANEOUS
3 A DAY
3
ORAL
3 DAILY
3
ORAL
3 Q12HRS
6
ORAL
3 TABLETS IN AM, TWO AT LUNCH TIME,
THREE AT DINNER, AND TWO AT
BEDTIME
10
ORAL
3 TABS (150MG) IN A.M. 2 TABS (100MG)
AT NOON, 3 TABS (150MG) IN P.M.
8
ORAL
3 TIMES DAILY
3
ORAL
3 X DAILY
3
ORAL
3,2,3 TABS 3X DAILY
8
ORAL
4 TABS DAILY
4
ORAL
4 TABS TID
12
ORAL
4 TIMES A DAY
4
ORAL
4 TIMES DAILY
4
ORAL
4-6 HRS
4
ORAL
4/DAY
4
ORAL
4QD
4
ORAL
5 ML (20 MG) BY MOUTH EVERY 4 HOURS
6
ORAL
5 PER DAY
5
ORAL
5 TABLETS A DAY
5
ORAL
5 TIMES A DAY
5
ORAL
5 TIMES DAILY
5
ORAL
5 TIMES PER DAY
5
ORAL
5 TIMES/DAY
5
ORAL
5 X DAILY
5
ORAL


Page 31 of 40
MEDFREQ
Analysis Frequency
ROUTE
5 X/ DAY
5
ORAL
5X DAY
5
ORAL
5X PER DAY
5
ORAL
5X QD
5
ORAL
6 PER DAY
6
ORAL
6 TABLETS PER DAY
6
ORAL
6 TIIMES PER DAY
6
ORAL
6 TIMES A DAY
6
ORAL
6 TIMES DAILY
6
ORAL
6 TIMES PER DAY
6
ORAL
6 X DAY
6
ORAL
6/DAY
6
ORAL
6X DAILY
6
ORAL
75 MCG/HR
1
CUTANEOUS
8 DAILY
8
ORAL
8 QD
8
ORAL
8 TIMES A DAY
8
ORAL
ALL 3 DAYS
1
CUTANEOUS
APPLY 1 PATCH Q 48 HOURS
1
CUTANEOUS
APPLY 1 PATCH TO SKIN EVERY 72
HOURS
1
CUTANEOUS
APPROXIMATELY ONCE MONTHLY, FOR
BREAKTHROUGHPAIN
0.033
ORAL
B.D.
2
ORAL
BD
2
ORAL
BID
2
ORAL
BID (10/325MG)
2
ORAL
BID - 10 MG IN AM, 20 MG IN PM
3
ORAL
BID TWICE DAILY
2
ORAL
BID-TWICE DAILY
2
ORAL
CONTINUOUS
1
INTRAMUSCULAR
DAILY
1
INTRAVENOUS
DAILY
1
NOT APPLICABLE
DAILY
1
ORAL
DAILY DOSE IS 6.5 MG. PER DAY
1
PARENTERAL
DAILY IN AM
1
ORAL
DAILY IN PM
1
ORAL
EVERY 12 HOURS
2
ORAL
EVERY 2 DAYS
1
CUTANEOUS


Page 32 of 40
MEDFREQ
Analysis Frequency
ROUTE
EVERY 2 HOURS
12
INTRAVENOUS
EVERY 3 DAY
1
CUTANEOUS
EVERY 3 DAYS
1
CUTANEOUS
EVERY 3 HOURS
8
INTRAVENOUS
EVERY 4 HOURS
6
ORAL
EVERY 4-6 HOURS
4
ORAL
EVERY 6 HOURS
4
INTRAVENOUS
EVERY 6 HOURS
4
ORAL
EVERY 6HR
4
ORAL
EVERY 72 HOURS
1
CUTANEOUS
EVERY 8 HOURS
3
ORAL
EVERY FOUR HOURS
6
ORAL
EVERY FOUR HOURS.
6
ORAL
EVERY HOUR
1
CUTANEOUS
EVERY OTHER DAY
1
CUTANEOUS
EVERY SIX HOURS DAILY
4
ORAL
EVERY SIX HOURS.
4
ORAL
EVERY TWO DAYS
1
CUTANEOUS
FIVE TIMES DAILY
5
ORAL
FOUR TIMES A DAY
4
ORAL
FOUR TIMES DAILY
4
ORAL
FOUR TIMES PER DAY
4
ORAL
FOUR TIMES PER DAY.
4
ORAL
HS
1
ORAL
HYDROCODONE/ACETAMINOPHEN
10-500
MG TO TAKE 1 TABLET THREE TIMES
DAILY
3
ORAL
ONCE
1
INTRAMUSCULAR
ONCE
1
INTRAVENOUS
ONCE A WEEK
1
CUTANEOUS
ONCE DAILY
1
ORAL
ONCE EVERY 2 DAYS
1
CUTANEOUS
ONCE PATCH FOR 72 HOURS
1
CUTANEOUS
ONE DAILY
1
ORAL
ONE PATCH EVERY 72 HRS
1
CUTANEOUS
ONE PATCH WEEKLY
1
CUTANEOUS
ONE PILL TID
3
ORAL
ONE TAB EVERY 4 HOURS
6
ORAL
ONE TABLET BY MOUTH THREE TIMES
DAILY
3
ORAL


Page 33 of 40
MEDFREQ
Analysis Frequency
ROUTE
ONE TABLET FIVE TIMES A DAY
5
ORAL
ONE TABLET THREE TIMES A DAY
3
ORAL
ONE TIME
1
INTRAMUSCULAR
ONE TIME
1
INTRAVENOUS
ONE TIME
1
ORAL
ONE TIME ONLY
1
INTRAVENOUS
PATCH IS CHANGED EVERY OTHER DAY
1
CUTANEOUS
Q 12 HOURS
2
ORAL
Q 12 HR
2
ORAL
Q 12H
2
ORAL
Q 3 DAYS
1
CUTANEOUS
Q 3-4 HR
6
ORAL
Q 4 HOURS
6
ORAL
Q 4 HOURS DAILY
6
ORAL
Q 4 HRS
6
ORAL
Q 4-6 HR
4
ORAL
Q 4-6H
4
ORAL
Q 48 HOURS
1
CUTANEOUS
Q 6 HOURS
4
ORAL
Q 6 HOURS, QID
4
ORAL
Q 6 HRS
4
ORAL
Q 6HRS
4
ORAL
Q 72 HOURS
1
CUTANEOUS
Q 8 HOURS
3
ORAL
Q 8 HRS
3
ORAL
Q.I.D
4
ORAL
Q12H
2
ORAL
Q12H-EVERY 12 HOURS
2
ORAL
Q2D
1
CUTANEOUS
Q2H
12
ORAL
Q3 DAYS
1
CUTANEOUS
Q36 HOURS
1
CUTANEOUS
Q3D
1
CUTANEOUS
Q3H
8
ORAL
Q4
6
ORAL
Q4 HOURS
6
ORAL
Q4-6 HR
4
ORAL
Q48 HOURS
1
CUTANEOUS
Q48 HRS
1
CUTANEOUS


Page 34 of 40
MEDFREQ
Analysis Frequency
ROUTE
Q4H
6
ORAL
Q4HOURS
6
ORAL
Q4HRS
6
ORAL
Q4HS
6
ORAL
Q5HOURS
5
ORAL
Q6
4
ORAL
Q6 HOURS
4
ORAL
Q6 HR
4
ORAL
Q6 HRS
4
ORAL
Q6H
4
ORAL
Q6H EVERY SIX HOURS
4
ORAL
Q6HOURS
4
ORAL
Q6HRS
4
ORAL
Q72HR
1
CUTANEOUS
Q72HRS
1
CUTANEOUS
Q8 HOURS
3
ORAL
Q8H
3
ORAL
Q8HRS
3
ORAL
QAM
1
ORAL
QD
1
INTRAVENOUS
QD
1
NOT APPLICABLE
QD
1
ORAL
QD
1
SUBCUTANEOUS
QD (PATIENT TAKES 30MG QAM AND
15MG QHS)
1
ORAL
QD - AT 1200
1
ORAL
QH-EVERY HOUR
1
CUTANEOUS
QHR
1
CUTANEOUS
QHS
1
ORAL
QID
4
ORAL
QID FOUR TIMES DAILY
4
ORAL
QID-FOUR TIMES DAILY
4
ORAL
QOD
0.5
ORAL
QPM
1
ORAL
SIX TIMES PER DAY
6
ORAL
TAKE ONE TABLET (5/325MG) BY MOUTH
EVERY 8 HOURS
3
ORAL
TAKE ONE TABLET BY MOUTH 2-3 TIMES
DAILY
2
ORAL


Page 35 of 40
MEDFREQ
Analysis Frequency
ROUTE
TAKE ONE TABLET BY MOUTH EVERY 6
HOURS
4
ORAL
TAKE ONE TABLET BY MOUTH FOUR
TIMES DAILY
4
ORAL
TAKE ONE TABLET BY MOUTH THREE
TIMES DAILY
3
ORAL
TAKE ONE TABLET BY MOUTH TWICE
DAILY
2
ORAL
TAKEN AT BEDTIME
1
ORAL
TAKEN EVERY 12 HOURS
2
ORAL
TAKEN EVERY 48 HOURS.
1
CUTANEOUS
TAKEN EVERY DAY AT BEDTIME
1
ORAL
TAKEN EVERY EIGHT HOURS.
3
ORAL
TAKEN EVERY FOUR HOURS
6
ORAL
TAKEN EVERY FOUR HOURS EVERY DAY
6
ORAL
TAKEN EVERY FOUR HOURS PER DAY.
6
ORAL
TAKEN EVERY SIX HOURS
4
ORAL
TAKEN EVERY SIX HOURS DAILY.
4
ORAL
TAKEN EVERY SIX HOURS PER DAY.
4
ORAL
TAKEN FOUR TIMES PER DAY
4
ORAL
TAKEN FOUR TIMES PER DAY.
4
ORAL
TAKEN SIX TIMES A DAY
6
ORAL
TAKEN THREE TIMES PER DAY
3
ORAL
TAKEN THREE TIMES PER DAY.
3
ORAL
TAKEN TWICE PER DAY
2
ORAL
TAKEN TWICE PER DAY.
2
ORAL
TAKES ONE 10/325MG TABLET BY MOUTH
TWICE DAILY
2
ORAL
THREE TIMES A DAY
3
ORAL
THREE TIMES DAILY
3
ORAL
THREE TIMES PER DAY
3
ORAL
TID
3
INTRAMUSCULAR
TID
3
ORAL
TID-QID
3
ORAL
TID-THREE TIMES DAILY
3
ORAL
TQ 4 HOURS (QID)
6
ORAL
TWICE
2
INTRAVENOUS
TWICE A DAY
2
ORAL
TWICE DAILY
2
ORAL
TWICE PER DAY
2
ORAL


Page 36 of 40
MEDFREQ
Analysis Frequency
ROUTE
TWICE PER DAY.
2
ORAL
TWICE TIMES PER DAY
2
ORAL
TWO TIMES PER DAY
2
ORAL
TWO TO THREE TIMES PER DAY
2
ORAL
UP TO 3 X DAILY
3
ORAL
Reported opioid medications will be converted to oral morphine equivalent doses as presented 
below in the table.  The conversion factors are derived from Table 1 in the SAP (Section 4.4.3).
A 1:100 equipotency ratio between buprenorphine and oral morphine is used to calculate 
morphine equivalent dose. The conversion factor for intravenous oxycodone, is derived from 
literature (iv oxycodone : iv morphine 2:3). The conversion factors presented below assume 
microgram units for fentanyl and buprenorphine and milligram units for other opioids. Route = 
"not applicable" refers to cases in which the subject is receiving opioids via intrathecal pump.
Intrathecal opioids are not included in the daily opioid dose." In the rare instances in which a 
fentanyl patch is recorded as a breakthrough medication, a continuous release of the drug 
substance for 72h is assumed and used in calculating the daily opioid dose.


Page 37 of 40
MEDPREF
ROUTE
MEDFORM
Analgesic
Multiplier
BUPRENORPHINE
CUTANEOUS
Buprenorphine
2.4
CODEINE
ORAL
Codeine
0.15
CODEINE
ORAL
Tablets
Codeine
0.15
CODEINE+PARACET
AMOL
ORAL
Codeine
0.15
CODEINE+PARACET
AMOL
ORAL
Tablets
Codeine
0.15
DIHYDROCODEINE
ORAL
Dihydrocodeine
0.15
DIHYDROCODEINE
BITARTRATE
ORAL
Dihydrocodeine
0.15
FENTANYL
CUTANEOUS
Fentanyl
3.6
FENTANYL
CUTANEOUS
Patches
Fentanyl
3.6
FENTANYL
INTRAVENOUS
Fentanyl
0.15
FENTANYL
CUTANEOUS
Fentanyl
3.6
FENTANYL
CITRATE
CUTANEOUS
Patches
Fentanyl
3.6
FENTANYL
CITRATE
OROMUCOSAL
(INCL.
SUBLINGUAL)
Lollipops
Fentanyl
0.0375
HYDROCODONE
ORAL
Hydrocodone
1.5


Page 38 of 40
MEDPREF
ROUTE
MEDFORM
Analgesic
Multiplier
HYDROCODONE
ORAL
Caplets
Hydrocodone
1.5
HYDROCODONE
ORAL
Capsules
Hydrocodone
1.5
HYDROCODONE
ORAL
Tablet
Hydrocodone
1.5
HYDROCODONE
ORAL
Tablets
Hydrocodone
1.5
HYDROCODONE+PA
RACETAMOL
ORAL
Hydrocodone
1.5
HYDROCODONE+PA
RACETAMOL
ORAL
Caplets
Hydrocodone
1.5
HYDROCODONE+PA
RACETAMOL
ORAL
Tablets
Hydrocodone
1.5
HYDROCODONE+PA
RACETAMOL
ORAL
tablet
Hydrocodone
1.5
HYDROMORPHONE
INTRAVENOUS
Hydromorphone
10
HYDROMORPHONE
ORAL
Hydromorphone
3.75
HYDROMORPHONE
HYDROCHLORIDE
INTRAMUSCUL
AR
Hydromorphone
10
HYDROMORPHONE
HYDROCHLORIDE
INTRAVENOUS
Hydromorphone
10
HYDROMORPHONE
HYDROCHLORIDE
NOT
APPLICABLE
Hydromorphone
0
HYDROMORPHONE
HYDROCHLORIDE
ORAL
Hydromorphone
3.75
HYDROMORPHONE
HYDROCHLORIDE
ORAL
Caplets
Hydromorphone
3.75
HYDROMORPHONE
HYDROCHLORIDE
ORAL
Tablets
Hydromorphone
3.75
METHADONE
ORAL
Methadone
3
METHADONE
ORAL
Tablets
Methadone
3
METHADONE
HYDROCHLORIDE
ORAL
Methadone
3
MORPHINE
INTRAMUSCUL
AR
Morphine
3
MORPHINE
INTRAMUSCUL
AR
Injection
Morphine
3
MORPHINE
INTRAVENOUS
Morphine
3
MORPHINE
NOT
APPLICABLE
Morphine
0
MORPHINE
ORAL
Morphine
1
MORPHINE
ORAL
Tablet
Morphine
1
MORPHINE
PARENTERAL
Morphine
3


Page 39 of 40
MEDPREF
ROUTE
MEDFORM
Analgesic
Multiplier
MORPHINE
SUBCUTANEOU
S
Morphine
3
MORPHINE
SULFATE
INTRAMUSCUL
AR
Morphine
3
MORPHINE
SULFATE
ORAL
Morphine
1
MORPHINE
SULFATE
ORAL
Capsules
Morphine
1
MORPHINE
SULFATE
ORAL
Tablets
Morphine
1
NALOXONE+OXYCO
DONE
ORAL
Oxycodone
1.5
OXYCODONE
ORAL
Oxycodone
1.5
OXYCODONE
ORAL
Tablet
Oxycodone
1.5
OXYCODONE
ORAL
Tablets
Oxycodone
1.5
OXYCODONE
ORAL
tablet
Oxycodone
1.5
OXYCODONE
HYDROCHLORIDE
INTRAVENOUS
Oxycodone
4.55
OXYCODONE
HYDROCHLORIDE
ORAL
Oxycodone
1.5
OXYCODONE
HYDROCHLORIDE
ORAL
Tablets
Oxycodone
1.5
OXYCODONE+PARA
CETAMOL
ORAL
Oxycodone
1.5
OXYCODONE+PARA
CETAMOL
ORAL
Caplets
Oxycodone
1.5
OXYCODONE+PARA
CETAMOL
ORAL
Tablets
Oxycodone
1.5
OXYMORPHONE
ORAL
Oxymorphone
3
OXYMORPHONE
HYDROCHLORIDE
ORAL
Oxymorphone
3
OXYMORPHONE
HYDROCHLORIDE
ORAL
Tablets
Oxymorphone
3
PARACETAMOL+TR
AMADOL
ORAL
Tramadol
0.2222
PARACETAMOL+TR
AMADOL
ORAL
Tablets
Tramadol
0.2222
PERCODAN
ORAL
Oxycodone
1.5
PETHIDINE
HYDROCHLORIDE
INTRAMUSCUL
AR
Pethidine
0.3


Page 40 of 40
MEDPREF
ROUTE
MEDFORM
Analgesic
Multiplier
PETHIDINE
HYDROCHLORIDE
INTRAMUSCUL
AR
ml
Pethidine
0.3
TAPENTADOL
ORAL
Tapentadol
0.25
TAPENTADOL
ORAL
Tablets
Tapentadol
0.25
TRAMADOL
ORAL
Tramadol
0.2222
TRAMADOL
ORAL
Capsules
Tramadol
0.2222
TRAMADOL
HYDROCHLORIDE
ORAL
Tramadol
0.2222
TRAMADOL
HYDROCHLORIDE
ORAL
Capsules
Tramadol
0.2222
TRAMADOL
HYDROCHLORIDE
ORAL
Tablets
Tramadol
0.2222