Clinical trial NCT01148225
Conditions: Uveitis
Keywords: Intermediate-Uveitis Non-infectious Uveitis Posterior-Uveitis Active Uveitis Pan-uveitis Uveitis
Sponsor: AbbVie
Start date: 2010-11-23; Completion date: 2018-05-21
Enrollment: 424 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long term efficacy and safety of adalimumab participants with non-infectious intermediate-, posterior- or pan-uveitis.

Detailed description:
This study was initially planned to run for 78 weeks but was extended for ethical reasons, to avoid leaving participants untreated who had responded well to adalimumab treatment, so that participants were allowed to remain in the study until regulatory and/or reimbursement approval for the treatment of uveitis in adults was obtained for their respective countries. Data were collected through Week 366 (maximum), but because of decreasing sample size that became too small toward the end of the study to allow for meaningful conclusion, data cut off for efficacy analyses (intent to treat \[ITT\] population) occurred at Week 246, as less than 10% of participants in the ITT set had visits beyond this timepoint.

Arms: arm 1: Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Interventions: intervention 1: adalimumab
Intervention descriptions: intervention 1: Adalimumab, pre-filled syringe, administered by SC injection

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
1
1.0
Title Page
Statistical Analysis Plan – Amendment 2
STUDY M11-327
A Multicenter Open-Label Study of the Long-term 
Safety and Efficacy of the Human Anti-TNF 
Monoclonal Antibody Adalimumab in Subjects with 
Non-infectious Intermediate, Posterior, or Panuveitis
07 July 2016
NCT01148225


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
2
Rationale for Changes
The changes to SAP Amendment 1 dated 09 March 2015 described in this amendment 
were necessary to include additional analyses.
Summary of Changes
●
Section 3.0:  updated protocol amendment, changed notation for non-
infectious intermediate, posterior and panuveitis and deleted IDMC section, 
since it was finished after second pivotal study terminated (Study M10-880)
●
Section 4.1:  changed notation for non-infectious intermediate, posterior and 
panuveitis
●
Section 4.2:  changed notation for non-infectious intermediate, posterior and 
panuveitis and changed study termination date
●
Section 6.2:  corrected First Rx Day column entry
●
Section 6.3:  added specification for interim analysis
●
Section 7.1:  changed labels for age variables
●
Section 7.5:  removed 'at baseline' next to IMMs and added abbreviation for 
corticosteroids
●
Section 8.0:  added additional category for interim analysis
●
Section 10.1:  added pooled analysis for efficacy variables
●
Section 10.2:  added new efficacy variables and additional analyses
●
Section 10.4:  added subgroups for some efficacy variables
●
Section 11.1:  added E/100PY for subgroup analysis of AEs and further 
subgroups
●
Section 13.0:  added new abbreviations
Full details of all changes are given in Section 15.0.
The amended Statistical Analysis Plan now reads as follows:


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
3
2.0
Table of Contents
1.0
Title Page..................................................................................1
2.0
Table of Contents.....................................................................3
3.0
Introduction .............................................................................5
4.0
Study Objectives, Design and Procedures.............................5
4.1
Objectives ..................................................................................................5
4.2
Design Diagram .........................................................................................5
5.0
Analysis Sets.............................................................................6
5.1
Definition for Analysis Sets.......................................................................6
6.0
Analysis Conventions ..............................................................7
6.1
Definition of Baseline and Final Observation............................................7
6.2
Definition of Rx Days and Visit Windows ................................................7
6.3
Imputation of Missing Data .......................................................................9
6.3.1
Non-Responder Imputation (NRI) .............................................................9
6.3.2
Last Observation Carried Forward (LOCF)...............................................9
6.3.3
Observed Case Analysis ............................................................................9
6.3.4
Imputation of Missing Dates....................................................................10
7.0
Demographics, Baseline Characteristics, Medical 
History, and Previous/Concomitant Medications ..............10
7.1
Demographic and Baseline Characteristics .............................................10
7.2
Uveitis History.........................................................................................13
7.3
Medical History .......................................................................................13
7.4
Prior Medications.....................................................................................13
7.5
Concomitant Medications ........................................................................14
8.0
Subject Disposition................................................................15
9.0
Study Drug Exposure and Compliance...............................16
10.0
Efficacy Analysis....................................................................17
10.1
General Considerations............................................................................17
10.2
Efficacy Variables....................................................................................17
10.3
Other Efficacy Variables..........................................................................23
10.4
Efficacy Subgroup Analyses....................................................................24
11.0
Safety Analysis.......................................................................25


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
4
11.1
Treatment-Emergent Adverse Events ......................................................25
11.2
Analysis of Laboratory Data....................................................................32
11.3
Analysis of Potentially Clinically Significant Laboratory Values...........33
11.4
Analysis of Liver Specific Laboratory Tests ...........................................34
11.5
Analysis of Vital Signs ............................................................................35
11.6
Analysis of Other Safety Variables..........................................................36
12.0
List of Tables, Figures and Data Listings that Are to 
be Programmed .....................................................................36
13.0
List of Abbreviations.............................................................37
14.0
References...............................................................................39
15.0
Summary of Changes............................................................40


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
5
3.0
Introduction
The SAP will provide details to further elaborate statistical methods as outlined in the 
protocol of Study M11-327, "A Multicenter Open-Label Study of the Long-term Safety 
and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects 
with Non-infectious Intermediate, Posterior, or Panuveitis" and will describe analysis 
conventions to guide the statistical programming work.  The analysis plan is based on 
protocol amendment 10 dated as of 04 June 2015.
Analyses described in this SAP comprise the analyses that will be performed by AbbVie 
after the study (including the total set of subjects from Japan and non-Japan) has been 
terminated.
All analyses will be performed using SAS®. 
4.0
Study Objectives, Design and Procedures
4.1
Objectives 
The primary objective of this study is to evaluate the long-term safety of adalimumab 
40 mg given every other week (eow) subcutaneously (SC) in subjects with non-infectious 
intermediate, posterior, or panuveitis who participated in Protocol M10-877 or 
Protocol M10-880.  Long-term efficacy will also be assessed.
4.2
Design Diagram
This study is a Phase 3, open-label multicenter study designed to evaluate long-term 
safety and efficacy of adalimumab in adult subjects with non-infectious intermediate, 
posterior, or panuveitis who have either discontinued from Study M10-877 or 
Study M10-880 for having met "Treatment Failure" criteria or have successfully 
completed Study M10-877 or Study M10-880.  Subjects, who prematurely discontinued 
from Study M10-877 or Study M10-880 for reasons other than for Treatment Failure as 
defined in the parent protocol, will not be eligible for this study.  Study visits will occur at 
Week 0, 2, 4, 8, 12, 18 and every 12 weeks thereafter.  Visits will occur every 12 weeks 




Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
7
●
Subjects undergoing a cataract surgery during the study.
●
Subjects that had previous vitrectomy or are vitrectomized during the study.
●
Subjects 
 from Investigator 
 
(
 France) will be excluded because of incomplete efficacy source data 
in studies M10-877 and M10-880. 
●
Subjects from Investigator 
 (
 USA) will be excluded because of 
general compliance issues in studies M10-877 and M10-880.
Both, the ITT set and the safety set will include subjects recruited in and outside Japan. 
6.0
Analysis Conventions
6.1
Definition of Baseline and Final Observation
Baseline of the parent study, Study M10-877/M10-880, is defined as the last non-missing 
observation made on or prior to the first dose of study drug in
Study M10-877/M10-880.
Baseline of Study M11-327 is defined as the last non-missing observation made on or 
prior to the first dose of study drug in Study M11-327.
The final observation is defined as the last non-missing observation available prior to last 
dose plus 70 days.
6.2
Definition of Rx Days and Visit Windows
Rx Days for efficacy analyses are calculated for each time point relative to the first 
adalimumab dose date in Study M11-327.  Rx days are negative values when the time 
point of interest is prior to the first adalimumab dose day.  Rx days are positive values
when the time point of interest is after the first adalimumab dose day.  The day of the first 
dose of adalimumab is defined as Rx Day 1, while the day prior to the first adalimumab 
dose is defined as Rx Day –1 (there is no Rx Day 0).  Rx Days are calculated as:


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
8
Rx Day
= Date of the measurement – Day 1 + 1 if date of measurement ≥ Day 1 date, or
= Date of the measurement – Day 1 if date of measurement < Day 1 date.
All time points and corresponding time windows for efficacy analyses are defined based 
on Rx Days for efficacy analyses.  If more than one assessment is included in a time 
window the assessment closest to the nominal day should be used.  If there were 
two observations equally distant to the nominal day, the latest one will be used in 
analyses.  If more than one assessment is included on the same day, then the last 
assessment on that day will be used in analyses.
The following visit windows will be used for efficacy analyses: 
Visit Windows
Week
Nominal Rx Day
First Rx Day
Last Rx Day
0
1
-
1
2
15
2
22
4
29
23
43
8
57
44
71
12
85
72
106
18
127
107
169
18+i*12a
127+i*84
170+(i-1)*84
169+i*84
a
i = 1, 2, 3, 4 etc.
Rx Days for safety analyses are calculated for each time point relative to the first 
adalimumab dose date in Study M10-877, M10-880 or M11-327.  Rx days are negative 
values when the time point of interest is prior to the first adalimumab dose day.  Rx days 
are positive values when the time point of interest is after the first adalimumab dose day.  
The day of the first dose of adalimumab is defined as Rx Day 1, while the day prior to the 
first adalimumab dose is defined as Rx Day –1 (there is no Rx Day 0).  


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
9
6.3
Imputation of Missing Data 
The following imputation methods will be used to impute missing values in the efficacy 
analyses.  In addition, an observed case analysis will be performed.
●
Non-Responder Imputation (NRI)
●
Last Observation Carried Forward (LOCF)
In case of an interim analysis, NRI and LOCF will be used.  Values will be imputed until 
that visit that the subject could have reached based on the cutoff date.
6.3.1
Non-Responder Imputation (NRI)
The NRI approach is used for binary variables.  These variables can take values of 
'Response' or 'Non-Response' or can be missing for any reason including discontinuation 
from study.  According to the NRI imputation approach, all missing values will be 
considered as non-response.
6.3.2
Last Observation Carried Forward (LOCF)
For all continuous and rating variables (excluding time to event data), the following rules 
will be used for the LOCF approach:
●
Baseline values will not be used to impute the missing post-baseline values for 
subjects with inactive uveitis.
●
Week 8 values will not be used to impute the missing post-baseline values for 
subjects with active uveitis.
●
Missing values after Rx Day 1 will be imputed using the latest non-missing 
value after Rx Day 1 and prior to the missing value.
6.3.3
Observed Case Analysis
Missing values will not be used for the observed case analysis.


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
10
6.3.4
Imputation of Missing Dates
For baseline, efficacy, and safety parameters, if the day and/or month are missing, the 
following conventions will be used to impute the missing dates:
●
01 for missing start day
●
End of month for missing end day
●
January 1 for missing start month
●
December 31 for missing end month
7.0
Demographics, Baseline Characteristics, Medical 
History, and Previous/Concomitant Medications
The subsequently described analyses will be provided by active uveitis (defined as having 
discontinued the parent study, Study M10-877/M10-880 due to Treatment Failure) versus 
inactive uveitis and overall in the ITT set.
All statistical analyses will be descriptive.  Descriptive statistics will include the number 
of observations, mean, standard deviation, minimum, first quartile, median, third quartile, 
and maximum for continuous variables; and counts and percentages for discrete variables.
7.1
Demographic and Baseline Characteristics
Variables to be summarized at baseline of Study M11-327 will include:  
●
Subject demographics
○
Age (years) 
○
Age categories 1 (< 40, 40 – 64, ≥ 65 years) 
○
Age categories 2 (< 30, ≥ 30 to < 50, ≥ 50 years)
○
Gender (male/female)
○
Race (white, black, Asian, American Indian/Alaska native, native 
Hawaiian or other Pacific islander, other)
○
Ethnicity (Hispanic or Latino, no ethnicity)


Adalimumab
M11-327 - Statistical Analysis Plan
Version 3.0 – 07 July 2016
11
○
Asian race (Chinese, Japanese, Korean, Taiwanese, Singaporean, 
Malaysian, other) (only for subjects from Japan)
●
TB history/PPD test/QuantiFERON®-TB Gold test/TB prophylaxis
○
BCG vaccination (yes, no)
○
Induration of Tuberculin PPD skin test (mm)
○
Tuberculin PPD skin test (negative, positive), positive defined as ≥ 5mm
○
QuantiFERON-TB Gold test (negative, positive, indeterminate)
○
Combined result of Tuberculin PPD skin test and QuantiFERON-TB Gold 
test
○
Enrollment under TB prophylaxis (yes, no)
●
Chest x-ray (only in subjects with positive TB test)
○
Chest x-ray findings (normal, abnormal)
○
Calcified granulomas (absent, present)
○
Pleural scarring (absent, present)
○
Pleural thickening (absent, present)
○
Findings indicative of previous TB infection (yes, no)
●
Vital signs
○
Systolic blood pressure (mmHg)
○
Diastolic blood pressure (mmHg)
○
Pulse (bpm)
○
Respiratory rate (rpm)
○
Temperature (°C)
●
Patient reported outcomes
○
Visual Functioning Questionnaire (VFQ-25): total score and subscale 
scores
○
EuroQol-5D Questionnaire (EQ-5D)
○
Work Productivity and Activity Impairment: Specific Health Problem 
Questionnaire (WPAI:SHP) and its components


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The following ophthalmologic variables will be summarized separately for left and right 
eye at baseline of Study M11-327:
●
Optical coherence tomography (OCT) evidence of macular edema (yes, no)
●
Central retinal thickness (microns)
●
Intraocular pressure (mmHg)
●
Active chorioretinal lesions (yes, no) via dilated indirect ophthalmoscopy 
(DIO)
●
Active retinal vascular lesions (yes, no) via DIO
●
Anterior chamber (AC) cell grade (SUN criteria) (continuous and categorical)
●
AREDS lens opacity grading (no statistical test):
○
nuclear opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
○
cortical opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
○
posterior subcapsular opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
●
Vitreous haze grades (NEI/SUN criteria) (continuous and categorical)
●
LogMAR Best corrected visual acuity (BCVA) will be calculated as follows:
○
if ≥ 20 letters were read at 4 m OR if < 20 letters were read at 4 m but the 
test was not done at 1 m,
logMAR = 1.7 – 0.02 * (number of letters read at 4 m + 30), 
○
if < 20 letters were read at 4 m and the test was also done at 1 m,
logMAR = 1.7 – 0.02 * (number of letters read at 4 m + number of 
letters read at 1 m)
○
if 0 letters were read at 1 m, the following logMAR values will be 
calculated according to Holladay (1997):
in case of finger counting:
logMAR = (–1)*log10(distance in meters/60)
in case of hand movements:  logMAR = 3.0
●
Power of sphere (diopters)
●
Power of cylinder (diopters)
●
Axis of cylinder (degrees)


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For analysis of central retinal thickness, the central retinal thickness measured by the 
investigator will be used.  Central retinal thickness will be analyzed by OCT machine.  
Central retinal thickness and macular edema will be analyzed excluding patients with 
macular hole and/or rhegmatogenous retinal detachment affecting the macular.  OCT 
evidence of macular edema will be defined as center point thickness ≥ 260 microns for 
Stratus, ≥320 microns for Cirrus, ≥ 340 microns for Spectralis.
7.2
Uveitis History
Variables to be summarized will include:
●
Duration of uveitis (months) at baseline of Study M11-327
●
Type of uveitis (intermediate, posterior, intermediate + posterior, panuveitis) at 
baseline of the parent study, Study M10-877/M10-880
●
Diagnosis (idiopathic, birdshot choroidopathy, multifocal choroiditis and 
panuveitis, Vogt Koyanagi Harada, sarcoid, Behcet's, Other) at baseline of the 
parent study, Study M10-877/M10-880
7.3
Medical History
Medical history data at baseline of the parent study, Study M10-877/M10-880, will be 
summarized and presented using body systems and conditions/diagnoses.  The body 
systems will be presented in alphabetical order and the conditions/diagnoses will be 
presented in alphabetical order within each body system.  The number and percentage of 
subjects with a particular condition/diagnosis will be summarized.  Subjects reporting 
more than one condition/diagnosis within a body system will be counted only once for 
that body system.
7.4
Prior Medications
Prior uveitis medications are defined as any uveitis-related medication discontinued prior 
to the first dose of study drug in the parent study, Study M10-877/M10-880.  Prior uveitis 
medication will be summarized by generic drug name.  In addition, the following 


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therapies discontinued prior to the first dose of study drug in the parent study, 
Study M10-877/M10-880 will be summarized by counts and percentages:
●
Immunosuppressants
○
Azathioprine
○
Cyclosporine
○
Methotrexate (MTX)
○
Mycophenolate mofetil or equivalent drug (e.g., mycophenolic acid)
○
Tacrolimus
●
Corticosteroids
○
Oral corticosteroids
○
Topical corticosteroids
○
Other corticosteroids
Previous medication is defined as any medication taken prior to the first dose of 
adalimumab in Study M11-327.  The number and percentage of subjects who had taken 
previous medications will be summarized by generic drug name based on the World 
Health Organization (WHO) drug dictionary.
7.5
Concomitant Medications
Medications with a start date prior to or on the first dose of adalimumab in 
Study M11-327 and a stop date on or after the first dose of adalimumab in 
Study M11-327 or a missing stop date will be considered as concomitant medications at 
baseline of Study M11-327.  If the start date is missing and the stop date is on or after the 
baseline date in Study M11-327, or if start and stop dates are both missing, the medication 
will also be considered as concomitant at baseline in Study M11-327.  The following 
therapies used by subjects at baseline in Study M11-327 will be summarized by counts 
and percentages:
●
Immunosuppressants (IMMs) 
○
Azathioprine


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○
Cyclosporine
○
Methotrexate (MTX)
○
Mycophenolate mofetil or equivalent drug (e.g. mycophenolic acid)
○
Tacrolimus
●
Corticosteroids (CSs)
○
Oral corticosteroids
○
Topical corticosteroids
○
Other corticosteroids
Concomitant medication is defined as any medication that started prior to the first dose of 
adalimumab in Study M11-327 and continued to be taken after the first dose of 
adalimumab in Study M11-327 or any medication that started after the first dose of 
adalimumab in Study M11-327, but not after the last dose of adalimumab in 
Study M11-327.  The number and percentage of subjects who had taken concomitant 
medications will be summarized by generic drug name based on the World Health 
Organization (WHO) drug dictionary.
8.0
Subject Disposition
The number of subjects in each of the following categories will be summarized.  The 
subsequently described analyses will be provided by country as well as by investigator 
and overall.  Additionally, tables will be stratified by the parent study, 
Study M10-877/M10-880:
●
Subjects who received at least one dose of study medication (safety set)
●
Subjects who received at least one dose of study medication (ITT set)
●
Subjects who completed (safety set)
●
Subjects who prematurely discontinued (safety set)
●
Subjects who are ongoing (safety set, in case of an interim analysis)


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The number and percentages of subjects by parent study, Study M10-877/M10-880, and 
treatment in the parent study will be presented overall for the safety set.
The number and percentage of subjects who prematurely discontinued study drug during 
the study will be summarized by reason overall for the safety set.
The number and percentage of subjects with protocol deviations will be presented overall 
for the safety set.
The number and percentage of subjects per visit will be presented overall for the safety 
set.
9.0
Study Drug Exposure and Compliance
Exposure to adalimumab in days (d) will be defined as follows: 
Treatment exposure (days)
= date of last dose of adalimumab in Study M11-327
– date of first dose of adalimumab in Study M11-327
+ 14 (days) 
In addition, the total amount of exposure from first adalimumab dose in 
Study M10-877/M10-880 will be calculated as follows:
Treatment exposure (days)
= date of last dose of adalimumab in Study M11-327
– date of first dose of adalimumab in Study M10-877/M10-880 or Study M11-327
+ 14 (days) 
Exposure will be presented in weeks.
Exposure will be summarized by number of subjects, mean, standard deviation, minimum, 
first quartile, median, third quartile and maximum in the safety set.  In addition, exposure 


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will be categorized and counts will be given for the number of subjects in the respective 
interval. 
Treatment compliance (%) is defined as the number of adalimumab injections received 
divided by the number of injections planned in Study M11-327.  Tabulations for treatment 
compliance will display the number of observations, mean, standard deviation, minimum, 
median and maximum.
10.0
Efficacy Analysis
10.1
General Considerations
The subsequently described analyses will be provided in the ITT set.  All statistical 
analyses will be descriptive.  Results will be stratified between subjects who entered into 
the study with active versus inactive uveitis.  For subjects who had inactive and subjects 
who had active uveitis when they entered the study, the efficacy analyses will start at 
Baseline of Study M11-327.  Results will also be provided overall except for efficacy 
variables defined differently for subjects entering Study M11-327 with active and inactive 
uveitis. 
10.2
Efficacy Variables
The following efficacy variables will be analyzed:
●
Proportion of subjects with no active lesions in both eyes at each study time 
point.
●
Proportion of subjects at each study time point with no new active, 
inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes 
relative to Baseline for subjects who had inactive uveitis when they entered the 
study and to Week 8 for subjects who had active uveitis when they entered the 
study.
●
AC cell grade left/right eye and mean of both eyes at each study time point.
●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in AC cells 
in both eyes on Slit Lamp Exam, according to SUN criteria.


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●
VH grades left/right eye and mean of both eyes at each study time point.
●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in vitreous 
haze in both eyes on indirect ophthalmoscopy, according to NEI/SUN criteria.
●
Proportion of subjects at each study time point with VH ≤ 0.5 and AC ≤ 0.5.
●
Proportion of subjects at each study time point with new lesions, AC ≥ 2 or 
VH ≥ 2.
●
Proportion of subjects at each study time point in quiescence defined as no 
active lesions, AC ≤ 0.5 and VH ≤ 0.5.
●
Proportion of subjects who experienced a uveitis flare (defined as no 
quiescence) during the study and who did or did not discontinue from the 
study due to the flare.
●
LogMAR Best corrected visual acuity (BCVA) left/right eye and mean of both 
eyes at each study time point.
●
Proportion of subjects at each study time point without a worsening of BCVA 
by ≥ 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in 
both eyes relative to Baseline for subjects who had inactive uveitis when they 
entered the study and to Week 8 for subjects who had active uveitis when they 
entered the study.
●
Proportion of subjects who started IMMs in Study M11-327.
●
Proportion of subjects on/off IMMs at each study time point only in subjects 
on IMMs at baseline of Study M11-327.
●
Proportion of subjects at each study time point achieving a ≥ 50% reduction in 
immunosuppression load relative to Baseline for subjects who had inactive 
uveitis when they entered the study and to Week 8 for subjects who had active 
uveitis when they entered the study.
●
Change in dose of IMM at each study time point relative to baseline for 
subjects who had inactive uveitis when they entered the study and to Week 8 
for subjects who had active uveitis when they entered the study only in 
subjects on IMMs at baseline/Week 8 of Study M11-327.
●
Proportion of subjects who started systemic CS in Study M11-327.
●
Systemic CS dose at each study time point.
●
Proportion of subjects at each study time point with 


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o
Systemic CS dose = 0 mg/day
o
Systemic CS dose > 0 to ≤ 5 mg/day
o
Systemic CS dose > 5 to ≤ 7.5 mg/day
o
Systemic CS dose > 7.5 to ≤ 10 mg/day 
o
Systemic CS dose > 10 to ≤ 20 mg/day
o
Systemic CS dose > 20 mg/day
●
Percent change in systemic CS dose at each study time point relative to 
baseline only in subjects on CS at baseline.
●
Proportion of subjects in steroid-free quiescence at each study time point.
●
Proportion of subjects in quiescence and for subjects without quiescence the 
proportion of subjects
o
with/without a change in concomitant medication (topical/systemic 
corticosteroids, immunosuppressants) within 5 days after non-quiescence 
and with/without quiescence at the next visit (at least 8 Weeks after 
non-quiescence)
o
with premature discontinuation
●
OCT evidence of macular edema in at least one eye at each study time point.
●
Central retinal thickness left/right eye and mean of both eyes at each study 
time point by OCT machine.
●
Percent change in central retinal thickness (1 mm subfield) in each eye at each 
study time point relative to Baseline for subjects who had inactive uveitis 
when they entered the study and to Week 8 for subjects who had active uveitis 
when they entered the study.
●
Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each 
study time point relative to Baseline for subjects who had inactive uveitis 
when they entered the study and to Week 8 for subjects who had active uveitis 
when they entered the study. 
For analysis of central retinal thickness, the central retinal thickness measured by the 
investigator will be used.  Changes and percent changes in central retinal thickness may 
only be calculated for measurements from the same machine.  Central retinal thickness 


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will be analyzed excluding patients with macular hole and/or rhegmatogenous retinal 
detachment affecting the macular.
Immunosuppression load will be assessed according to the article by Nussenblatt 
et al. (2005).  The below grading scheme will be used to accommodate the simultaneous 
use of multiple agents and provide a combined, single numeric score for the total 
immunosuppression load per unit body weight per day at each visit.  For patients 
receiving multiple medications, the sum of the grading scores for each drug will be used 
to calculate a total immunosuppression score at each visit.


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Immunosuppression Grade Based on Dose in mg/kg/day (or per Week if Dosed Weekly)
Medication
0
1
2
3
4
5
6
7
8
9
Prednisone
0
< 0.15
0.15 – 0.30
0.31 – 0.45
0.46 – 0.60
0.61 – 0.75
0.76 – 0.90
0.91 – 1.05
1.06 – 1.20
> 1.20
Cyclosporine
0
< 0.75
0.75 – 1.50
1.51 – 2.25
2.26 – 3.00
3.01 – 3.75
3.76 – 4.50
4.51 – 5.25
5.26 – 6.00
> 6.00
Azathioprine
0
< 0.25
0.25 – 0.50
0.51 – 0.75
0.76 – 1.00
1.01 – 1.25
1.26 – 1.50
1.51 – 1.75
1.76 – 2.00
> 2.00
Mycophenolate
0
< 10
10 – 20
21 – 30
31 – 40
41 – 50
51 – 60
> 60
-
-
Methotrexate
0
< 0.05
0.05 – 0.10
0.11 – 0.15
0.16 – 0.20
0.21 – 0.25
0.26 – 0.30
0.31 – 0.35
0.36 – 0.40
> 0.40
Cyclophosphamide
0
< 0.25
0.25 – 0.50
0.51 – 0.75
0.76 – 1.00
1.01 – 1.25
1.26 – 1.50
1.51 – 1.75
1.76 – 2.00
> 2.00
Chlorambucil
0
< 0.025
0.025 – 0.050
0.051 – 0.075
0.076 – 0.100
0.101 – 0.125
0.126 – 0.150
0.151 – 0.175
0.176 – 0.200
> 0.200
Note:
Dose ranges are for the average in mg/kg/day, except for weekly doses of methotrexate, which are measured as mg/kg/week


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The efficacy variables will be analyzed as follows.
Descriptive statistics for quantitative variables will include the number of observations, 
mean, standard deviation, minimum, first quartile, median, third quartile, and maximum 
for values at each visit, changes from Baseline/Week 8 to each visit thereafter and change 
from Baseline/Week 8 to Final/Early Termination Visit for continuous variables.  In 
addition, for central retinal thickness percent change from Baseline/Week 8 to each visit 
thereafter and percent change from Baseline/Week 8 to Final/Early Termination Visit will 
be analyzed.  For central retinal thickness, values at each visit and changes will be 
analyzed by OCT machine, percent changes will be analyzed overall.  95% confidence 
intervals for means will be provided. Data will be analyzed by Last Observation Carried 
Forward (LOCF) and as observed.  For as observed analyses, graphs will be generated for 
subjects with active vs. inactive uveitis at entry of Study M11-327 for:
●
LogMAR Best corrected visual acuity (BCVA) (mean of both eyes) at each 
study time point.
●
Systemic CS dose at each study time point.
●
Central retinal thickness (mean of both eyes) at each study time point by OCT 
machine.
Categorical variables will be summarized by counts and percentages at each visit.  
95% confidence intervals for proportions will be provided.  Data will be analyzed by Non 
Responder Imputation (NRI) and as observed.  For as observed analyses, graphs will be 
generated for subjects with active vs. inactive uveitis at entry of Study M11-327 for: 
●
Proportion of subjects with no active lesions in both eyes at each study time 
point.
●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in AC cells 
in both eyes on Slit Lamp Exam, according to SUN criteria.
●
Proportion of subjects at each study time point with Grade ≤ 0.5+ in vitreous 
haze in both eyes on indirect ophthalmoscopy, according to NEI/SUN criteria.


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●
Proportion of subjects at each study time point in quiescence defined as no 
active lesions, AC ≤ 0.5 and VH ≤ 0.5.
●
Proportion of subjects with steroid-free quiescence at each study time point.
●
OCT evidence of macular edema in at least one eye at each study time point.
10.3
Other Efficacy Variables
The following other efficacy variables will be analyzed:
●
Work Productivity and Activity Impairment, Questionnaire:  Specific Health 
Problem Questionnaire (WPAI:SHP) and its components
●
EuroQol Questionnaire (EQ-5D)
●
Health Resource Utilization Questionnaire (HRU)
These other efficacy variables will be analyzed as follows.
For WPAI:  SHP and EQ-5D, descriptive statistics will include the number of 
observations, mean, standard deviation, minimum, first quartile, median, third quartile, 
and maximum for values at each visit, changes from Baseline/Week 8 to each visit 
thereafter and change from Baseline/Week 8 to Final/Early Termination Visit for 
continuous variables.  Data will be analyzed by Last Observation Carried Forward 
(LOCF) and as observed. 
For HRU data, the individual cumulative number of utilizations per time under 
observation in Study M11-327 will be calculated in each category (i.e., unscheduled 
uveitis-related health care professional visits, emergency room visits, hospital admissions 
and the total number of days in hospital) as follows:
●
Time under observation for a subject will be defined as "date of last visit with 
non-missing HRU – date of Baseline/Week 8 for subjects with inactive/active 
uveitis."
●
The number of utilizations (documented starting at Week 2/Week 12 for 
subjects with inactive/active uveitis) will be summed up for each subject.


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For cumulative HRU data, the ratio of the total number of utilizations (i.e., separately over 
all subjects with inactive and active uveitis) and the total time under observation 
(i.e., separately over all subjects with inactive and active uveitis) will be calculated across 
all subjects.  HRU will be analyzed as observed only.
10.4
Efficacy Subgroup Analyses
The following efficacy variables will be analyzed as described in Section 10.2 by pooling 
subjects with active and inactive uveitis at start of Study M11-327
●
Proportion of subjects with no active lesions in both eyes at each study time 
point.
●
AC cell grade (mean of both eyes) at each study time point.
●
Proportion of subjects with a Grade ≤ 0.5+ in AC cells in both eyes on Slit 
Lamp Exam, according to SUN criteria at each study time point.
●
VH grades (mean of both eyes) at each study time point.
●
Proportion of subjects at each study time point with Grade ≤ 0.5+ in vitreous 
haze in both eyes on indirect ophthalmoscopy, according to NEI/SUN criteria.
●
Proportion of subjects at each study time point in quiescence defined as no 
active lesions, AC ≤ 0.5 and VH ≤ 0.5.
●
LogMAR Best corrected visual acuity (BCVA) (mean of both eyes) at each 
study time point.
●
Proportion of subjects who started IMMs in Study M11-327.
●
Systemic CS dose at each study time point.
●
Proportion of subjects with steroid-free quiescence at each study time point.
●
OCT evidence of macular edema in at least one eye at each study time point.
●
Central retinal thickness (mean of both eyes) at each study time point by OCT 
machine.
in the following subgroups:
●
Gender (male/female)


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●
Duration of uveitis (< 1, ≥ 1 years)
●
Type of uveitis (intermediate versus posterior versus panuveitis)
●
Diagnosis (idiopathic/other versus birdshot choroidopathy versus multifocal 
choroiditis and panuveitis versus Vogt Koyanagi Harada versus sarcoid versus 
Behcet's)
●
IMM usage at Baseline of Study M11-327 (yes, no)
In addition, the efficacy variable "Proportion of subjects at each study time point without 
a worsening of BCVA by ≥ 15 letters on the ETDRS in both eyes relative to Baseline for 
subjects who had inactive uveitis when they entered the study and to Week 8 for subjects 
who had active uveitis when they entered the study" will be analyzed as described in 
Section 10.2 in the following subgroups:
●
Subjects with/without AE "posterior capsule opacification/rupture"
11.0
Safety Analysis
The subsequently described analyses will be provided overall in the safety set.
11.1
Treatment-Emergent Adverse Events
Treatment-emergent adverse events (AEs) are defined as any event with an onset date that 
is on or after the first dose of adalimumab in Study M11-327 and no more than 70 days 
after the last dose of study drug administration.
If an incomplete onset date was collected for an AE, the event will be assumed to be 
treatment emergent unless there is other evidence that confirms that the event was not 
treatment emergent (e.g., the event end date was prior to the study drug start date).  In 
case of increasing severity of an existing AE, the worsening will be considered as a new 
AE with a new onset date.
AE data will be summarized using primary MedDRA system organ classes (SOCs) and 
preferred terms (PTs) according to the most current implemented version of the MedDRA 


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coding dictionary.  The SOCs will be presented in alphabetical order and the PTs will be 
presented in alphabetical order within each SOC.  For AEs with an incidence rate ≥ 5% in 
the adalimumab group and SAEs, the PTs will also be presented in decreasing frequency.
Adverse Event Overview
The number and percentage of subjects experiencing treatment-emergent AEs will be 
summarized for the following AE categories. 
●
AEs
●
AEs rated at least possibly related to study drug by the investigator (Probably 
Related or Possibly Related)
●
Severe AEs
●
SAEs
●
SAEs rated at least possibly related to study drug by the investigator (Probably 
Related or Possibly Related)
●
AEs leading to discontinuation of study drug
●
AEs leading to death
●
Uveitis-related AEs (see below)
●
AEs of special interest (see below)
Uveitis-related AEs will be:
●
Loss of transparency of the cornea
●
Band keratopathy
●
Synechiae
●
Cataracts
●
Glaucoma/increased intraocular pressure
●
Vitreous hemorrhage
●
Macular edema
●
Retinal detachment
●
Epiretinal membrane


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●
Vitreo-macular traction
●
Retinal ischemia
●
Vision loss
●
Hypotony
The current list of AEs of special interest for treatment with adalimumab is:


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Infection
    All Infections  
    Serious Infection
    Legionella Infection
    Diverticulitis
    Opportunistic Infection Excluding Oral Candidiasis and TB
    Oral Candidiasis
    Tuberculosisa
        Active Tuberculosisa
        Latent Tuberculosisa
    Parasitic Infections
    Reactivation of Hepatitis B
    Progressive Multifocal Leukoencephalopathy (PML)
Malignancies
    Malignancies
    Lymphoma
    Hepatosplenic T-Cell Lymphomas (HSTCL)
    Non-Melanoma Skin Cancer (NMSC)
    Melanoma
    Leukaemia
    Other Malignancies Except Lymphoma, HSTCL, Leukemia, NMSC, and Melanoma
Immune Reactions
    Allergic Reactions Including Angioedema, Anaphylaxis
    Lupus-Like Reactions and Systemic Lupus Erythematosus (SLE)
    Vasculitisa
         Cutaneous Vasculitisa
         Non-Cutaneous Vasculitisa
    Sarcoidosis
    Autoimmune Hepatitis
Cardiovascular/Vascular
    Myocardial Infarction
    Cerebrovascular Accident
    Congestive Heart Failure
    Pulmonary Embolism


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Respiratory
    Interstitial Lung Disease
Gastrointestinal Events
    Intestinal Perforation
    Pancreatitis
Skin and Subcutaneous Tissue Disorders
    Steven's Johnson Syndrome
    Erythema Multiforme
    Worsening and New Onset of Psoriasis 
Nervous System Disorder
    Demyelinating Disorders Including Multiple Sclerosis, Guillain-Barré Syndrome, and Optic Neuritis 
and Others
   Amyotrophic Lateral Sclerosis
    Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Hematologic Events
    Hematologic Disorders Including Pancytopenia
Hepatic Events
    Liver Failure and Other Liver Events (Except Gallbladder-Related Events)
Other
    Humira Administration-related Medication Errors 
    Injection Site Reactions
a.
An additional column will be included in the spreadsheet to indicate the subcategories:  active or non-active 
tuberculosis, cutaneous or non-cutaneous vasculitis.
This list might be modified at time of analysis to comply with any future version.
Adverse Events by System Organ Class and Preferred Term
The number and percentage of subjects experiencing AEs will be tabulated according to 
the primary MedDRA SOC and PT for each treatment group.  Subjects reporting more 
than one AE for a given PT will be counted only once for that term (most severe incident 
for the severity tables and most related incident for the relationship tables).  Subjects 
reporting more than one type of AE within a SOC will be counted only once for that SOC.  
Subjects reporting more than one type of AE will be counted only once in the overall 
total.  


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The following AEs will be summarized using the conventions described above:
●
AEs
●
AEs rated at least possibly related to study drug by the investigator
●
AEs by highest relationship
●
AEs by maximum severity
●
SAEs
●
AEs leading to discontinuation of study drug
●
AEs leading to death
●
AEs of special interest
A listing of subject numbers associated with AEs by SOC and PT will be provided.
By-subject listings will be provided for AEs at least possibly related to study drug, severe 
AEs, SAEs, AEs leading to discontinuation, AEs leading to death, and AEs of special 
interest.  In addition, SAEs with onset after informed consent but before the first dose of 
adalimumab was administered will be considered as pre-treatment SAEs and will be listed 
separately.
Adverse Events by Maximum Severity
Adverse events will also be summarized by maximum severity.  If a subject has an 
adverse event with unknown severity, then the subject will be counted in the severity 
category of "unknown," even if the subject has another occurrence of the same event with 
a severity present.  The only exception is if the subject has another occurrence of the same 
adverse event with the most extreme severity – "Severe."  In this case, the subject will be 
counted under the "Severe" category.
Adverse Events by Maximum Relationship
Adverse events will also be summarized by maximum relationship to study, as assessed 
by the investigator.  If a subject has an adverse event with unknown relationship, then the 
subject will be counted in the relationship category of "unknown," even if the subject has 


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another occurrence of the same event with a relationship present.  The only exception is if 
the subject has another occurrence of the same adverse event with a relationship 
assessment of "Probably Related" or "Possibly Related."  In this case, the subject will be 
counted under the "Probably Related" or "Possibly Related" category, respectively.
Adverse Event Rates per 100 Subject-Years of Study Drug Exposure
The analysis of AEs per 100 subject-years will be presented for the AE overview, for AEs 
by SOC and PT, and for SAEs by SOC and PT.
The treatment-emergent AE rate per 100 subject-years of exposure to study drug (ADA) 
will be calculated.  For this calculation, one year will be considered to be 365.25 days.  
The numerator of the rate will be the total number of AEs reported that is a subject can be 
counted more than once overall.  The denominator of the rates will be the total number of 
days exposed to study drug summed across all treated subjects divided by 365.25.  The 
AE rate per 100 subject-years of exposure will be calculated as 
[(numerator/denominator)]*100.  The number of AEs reported (numerator), the total 
number of years of study drug exposure (denominator), and the AE rate per 
100 subject-years will be presented overall.
Subgroup Analyses of Adverse Events 
Analyses of AEs per subgroup will be presented for the AE overview.  The number and 
percentage of subjects experiencing AEs as well as E/100PYs will be tabulated overall. 
Subgroups used for the analyses are:
●
Concomitant use of corticosteroids (yes, no)
●
Baseline immunosuppressant usage (yes, no)
●
Baseline azathioprine usage
●
Baseline cyclosporine usage
●
Baseline methotrexate usage


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●
Baseline mycophenolate mofetil or an equivalent drug (e.g., mycophenolic 
acid) usage
●
Baseline tacrolimus usage
An AE overview (with number and percentage of subjects experiencing treatment-
emergent AEs as well as E/100PYs) will also be presented separately for
●
treatment periods with/without concomitant use of corticosteroids
●
treatment periods with corticosteroid dose > 0 to ≤ 15 mg/day
●
treatment periods with corticosteroid dose > 15 mg/day
●
treatment periods with/without concomitant use of immunosuppressant
●
treatment periods
○
without concomitant use of corticosteroids and immunosuppressant
○
with concomitant use of corticosteroids only
○
with concomitant use of immunosuppressant only
○
with concomitant use of corticosteroids and immunosuppressant
11.2
Analysis of Laboratory Data
Hematology variables include: hematocrit, hemoglobin, red blood cell (RBC), white 
blood cell (WBC), WBC differentials (neutrophils, lymphocytes, monocytes, basophils, 
eosinophils), and platelet count.
Clinical chemistry variables include:  blood urea nitrogen (BUN), creatinine, total 
bilirubin, ALT (SGPT), AST (SGOT), alkaline phosphatase, sodium, potassium, calcium, 
inorganic phosphorus, uric acid, cholesterol, total protein, glucose, triglycerides, and 
albumin.
Urinalysis variables include:  specific gravity, pH.
For quantitative laboratory parameters, mean changes from baseline in Study M11-327 to 
the minimum value, maximum value, and final value in the laboratory variables will be 


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summarized with the baseline mean, min/max/final mean, change from baseline mean, 
standard deviation, and median.
Laboratory data values will be categorized as low, normal, or high based on normal 
ranges of the laboratory used in this study.  Shift tables from baseline in Study M11-327 
to final values will be created.  The shift tables cross tabulate the frequency of subjects 
with baseline values below/within/above the normal range versus final values 
below/within/above the normal range.
11.3
Analysis of Potentially Clinically Significant Laboratory 
Values
For selected laboratory parameters (hematology:  Hemoglobin, Lymphocytes, 
Neutrophils, Platelet Count, WBC; clinical chemistry:  Albumin, Alkaline Phosphatase, 
ALT, AST, Total Bilirubin, Calcium, Cholesterol, Creatinine, Glucose, Inorganic 
Phosphorus, Potassium, Sodium, Triglycerides) with Common Toxicity Criteria (CTC) 
criteria, Potentially Clinically Significant Laboratory Findings (Common Toxicity Criteria 
CTC Grades 3 and 4) will be assessed.
For definition of CTC V3.0 criteria, see http://ctep.cancer.gov/reporting/ctc.html.
The following table describes the Criteria for Potentially Clinically Significant Laboratory 
Findings:


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Laboratory 
Parameter
CTC Grade 1
CTC Grade 2
CTC Grade 3
CTC Grade 4
Hemoglobin
< LLN – 100 g/L
< 100 – 80 g/L
< 80 – 65 g/L
< 65 g/L
Lymphocytes
< LLN – 0.8 × 109/L
< 0.8 – 0.5 × 109/L
< 0.5 – 0.2 × 109/L
< 0.2 × 109/L
Neutrophils
< LLN – 1.5 × 109/L
< 1.5 – 1.0 × 109/L
< 1.0 – 0.5 × 109/L
< 0.5 × 109/L
Platelet count
< LLN – 75.0 × 109/L
< 75.0 – 50.0 × 109/L
< 50.0 – 25.0 × 109/L
< 25.0 × 109/L
WBC
< LLN – 3.0 × 109/L
< 3.0 – 2.0 × 109/L
< 2.0 – 1.0 × 109/L
< 1.0 × 109/L
Albumin
< LLN – 30 g/L
< 30 g/L – 20 g/L
< 20 g/L
—
Alkaline 
Phosphatase
> ULN – 2.5 × ULN
> 2.5 – 5.0 × ULN
> 5.0 – 20.0 × ULN
> 20.0 × ULN
ALT 
> ULN – 2.5 × ULN
> 2.5 – 5.0 × ULN
> 5.0 – 20.0 × ULN
> 20.0 × ULN
AST
> ULN – 2.5 × ULN
> 2.5 – 5.0 × ULN
> 5.0 – 20.0 × ULN
> 20.0 × ULN
Total 
Bilirubin
> ULN – 1.5 × ULN
> 1.5 – 3.0 × ULN
> 3.0 – 10.0 × ULN
> 10.0 × ULN
Calcium
> ULN – 2.9 mmol/L 
< LLN – 2.0 mmol/L
> 2.9 – 3.1 mmol/L 
< 2.0 – 1.75 mmol/L
> 3.1 – 3.4 mmol/L 
< 1.75 – 1.5 mmol/L
> 3.4 mmol/L 
< 1.5 mmol/L
Cholesterol
> ULN – 7.75 mmol/L
> 7.75 – 10.34 mmol/L
> 10.34 – 12.92 mmol/L
> 12.92 mmol/L
Creatinine
> ULN – 1.5 × ULN
> 1.5 – 3.0 × ULN
> 3.0 – 6.0 × ULN
> 6.0 × ULN
Glucose
> ULN – 8.9 mmol/L 
< LLN – 3.0 mmol/L
> 8.9 – 13.9 mmol/L 
< 3.0 – 2.2 mmol/L
> 13.9 – 27.8mmol/L 
< 2.2 – 1.7 mmol/L
> 27.8 mmol/L 
< 1.7 mmol/L
Inorganic 
Phosphorus
< LLN – 0.8 mmol/L
< 0.8 – 0.6 mmol/L
< 0.6 – 0.3 mmol/L
< 0.3 mmol/L
Potassium
> ULN – 5.5 mmol/L 
< LLN – 3.0 mmol/L
> 5.5 – 6.0 mmol/L 
—
> 6.0 – 7.0 mmol/L 
< 3.0 – 2.5 mmol/L
> 7.0 mmol/L 
< 2.5 mmol/L
Sodium
> ULN – 150mmol/L 
< LLN – 130mmol/L
> 150 – 155mmol/L 
—
> 155 – 160mmol/L 
< 130 – 120 mmol/L
> 160 mmol/L 
< 120 mmol/L
Triglycerides
> ULN – 2.5 × ULN
> 2.5 – 5.0 × ULN
> 5.0 – 10 × ULN
> 10 × ULN
LLN = lower limit of normal range; ULN = upper limit of normal range
Shift tables from baseline value in Study M11-327 to worst value will be created.  The 
shift tables cross tabulate the frequency of subjects with baseline values with 
CTC<3/CTC≥3 versus worst values with CTC<3/CTC≥3.  Furthermore, for subjects with 
laboratory values with CTC ≥ 3, the whole course of the parameter will be listed.
11.4
Analysis of Liver Specific Laboratory Tests
The liver specific laboratory tests include ALT/SGPT, AST/SGOT, alkaline phosphatase 
and total bilirubin.  Each of these laboratory values will be categorized as follows:


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1.
< 1.5 × ULN,
2.
≥ 1.5 × ULN TO < 3 × ULN,
3.
≥ 3 × ULN TO < 5 × ULN,
4.
≥ 5 × ULN TO < 8 × ULN, and
5.
≥ 8 × ULN, 
where ULN is the upper normal limit.
For each variable, shift tables will be generated that cross tabulate the number of subjects 
with baseline values in Study M11-327 in these 5 categories versus the min/max/final 
value in these 5 categories.
A listing of potentially clinically significant liver function laboratory values will be 
provided.  The listing will include all subjects who meet any of the following 4 criteria:
1.
ALT ≥ 2.5 × ULN, or
2.
AST ≥ 2.5 × ULN, or
3.
Alkaline phosphatase ≥ 2.5 × ULN, or
4.
Total bilirubin ≥ 1.5 × ULN.
11.5
Analysis of Vital Signs
Vital signs include:  Blood Pressure (Systolic/Diastolic) (mmHg), Pulse (bpm), 
Respiratory Rate (rpm), Temperature (°C).
Mean changes from baseline in Study M11-327 to the minimum value, maximum value, 
and final value in the vital signs variables will be summarized with the baseline mean, 
min/max/final mean, change from baseline mean, standard deviation, and median. 


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11.6
Analysis of Other Safety Variables
Other safety variables are:
●
Intraocular pressure (0–9, 10–21, 22-25, 26-30, > 30 mmHg)
●
Nuclear opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
●
Cortical lens opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
●
Posterior subcapsular opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
●
2-step increase in lens opacity (defined as change from grade < 1.0 to 2.5 or 
higher, from 1.0 to 3.0 or higher, or from 1.5 to > 3.0) in at least one eye in at 
least one of the three opacity variables
For each variable, shift tables will be generated that cross tabulate the number of subjects 
with baseline values in Study M11-327 in the above categories versus the worst 
observations (i.e., largest values) in these categories.
12.0
List of Tables, Figures and Data Listings that Are to 
be Programmed
Will be provided in a separate document.


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13.0
List of Abbreviations
AC
Anterior Chamber
AE
Adverse Event
ALT
Alanine Aminotransferase
AST
Aspartate Aminotransferase
BCVA
Best Corrected Visual Acuity
BUN
CS
Blood Urea Nitrogen
Corticosteroid
CTC
Common Toxicity Criteria
DIO
Dilated Indirect Ophthalmoscopy
eow
Every Other Week
EQ-5D
EuroQol Questionnaire
ETDRS
Early Treatment Diabetic Retinopathy Study
HRU
Health Resource Utilization Questionnaire
IDMC
Independent Data Monitoring Committee
IMM
Immunosuppressant
ITT
Intent-to-Treat
LFT
Liver Function Test
LOCF
Last Observation Carried Forward
MedDRA
Medical Dictionary for Regulatory Activities
MTX
Methotrexate
NEI
National Eye Institute
NMSC
Non-Melanoma Skin Cancer
NRI
Non-Responder Imputation
OCT
Optical Coherence Tomography
PT
Preferred Term
RBC
Red Blood Cell 
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SGOT
Serum Glutamic-Oxaloacetic Transaminase
SGPT
Serum Glutamic-Pyruvic Transaminase
SOC
System Organ Class
SUN
Standardization of Uveitis Nomenclature


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ULN
VH
Upper Limit Normal
Vitreous Haze
VFQ
Visual Functioning Questionnaire
WBC
White Blood Cell
WHO
World Health Organization
WPAI:SHP
Work Productivity and Activity Impairment Questionnaire:  Specific Health 
Problem Questionnaire


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14.0
References
1.
Nussenblatt RB, Peterson JS, Foster CS, Rao NA, See RF, Letko E, et al.  Initial 
evaluation of subcutaneous daclizumab treatments for noninfectious uveitis.  
Ophthalmology.  2005:112:764-70.
2.
Holladay JT.  Proper method for calculating average visual acuity.  J Refract Surg.  
1997;13(4):388-91.


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15.0
Summary of Changes
Details of changes in Amendment 2 to the Statistical Analysis Plan:
Section 3.0
Section previously read:
The SAP will provide details to further elaborate statistical methods as outlined in the 
protocol of Study M11-327, "A Multicenter Open-Label Study of the Long-term Safety 
and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects 
with Non-infectious Intermediate-, Posterior-, or Pan-uveitis" and will describe analysis 
conventions to guide the statistical programming work.  The analysis plan is based on 
protocol amendment 9 dated as of 26 June 2013.
The Independent Data Monitoring Committee is established for the study to 
independently monitor and assess data from the study.  At each safety review meeting, the 
IDMC will undertake a comprehensive review and assessment of the safety data.  Details 
on analyses prepared for the IDMC meetings are to be found in a separate SAP.
Analyses described in this SAP comprise the analyses that will be performed by AbbVie 
after the study (including the total set of subjects from Japan and non-Japan) has been 
terminated.
All analyses will be performed using SAS®. 
Has been changed to read:
The SAP will provide details to further elaborate statistical methods as outlined in the 
protocol of Study M11-327, "A Multicenter Open-Label Study of the Long-term Safety 
and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects 
with Non-infectious Intermediate, Posterior, or Panuveitis" and will describe analysis 


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conventions to guide the statistical programming work.  The analysis plan is based on 
protocol amendment 10 dated as of 04 June 2015.
Analyses described in this SAP comprise the analyses that will be performed by AbbVie 
after the study (including the total set of subjects from Japan and non-Japan) has been 
terminated.
All analyses will be performed using SAS®. 
Section 4.1
Section previously read:
The primary objective of this study is to evaluate the long-term safety of adalimumab 
40 mg given every other week (eow) subcutaneously (SC) in subjects with non-infectious 
intermediate-, posterior-, or pan-uveitis who participated in Protocol M10-877 or 
Protocol M10-880.  Long-term efficacy will also be assessed.
Has been changed to read:
The primary objective of this study is to evaluate the long-term safety of adalimumab 
40 mg given every other week (eow) subcutaneously (SC) in subjects with non-infectious 
intermediate, posterior, or panuveitis who participated in Protocol M10-877 or 
Protocol M10-880.  Long-term efficacy will also be assessed.
Section 4.2
Section previously read:
This study is a Phase 3, open-label multicenter study designed to evaluate long-term 
safety and efficacy of adalimumab in adult subjects with non-infectious intermediate-, 
posterior-, or pan-uveitis who have either discontinued from Study M10-877 or 
Study M10-880 for having met "Treatment Failure" criteria or have successfully 
completed Study M10-877 or Study M10-880.  Subjects who prematurely discontinued 






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Has been changed to read:
The following visit windows will be used for efficacy analyses: 
Visit Windows
Week
Nominal Rx Day
First Rx Day
Last Rx Day
0
1
-
1
2
15
2
22
4
29
23
43
8
57
44
71
12
85
72
106
18
127
107
169
18+i*12a
127+i*84
170+(i-1)*84
169+i*84
a
i = 1, 2, 3, 4 etc.
Section 6.3
Section previously read:
The following imputation methods will be used to impute missing values in the efficacy 
analyses.  In addition, an observed case analysis will be performed.
●
Non-Responder Imputation (NRI)
●
Last Observation Carried Forward (LOCF)
Has been changed to read:
The following imputation methods will be used to impute missing values in the efficacy 
analyses.  In addition, an observed case analysis will be performed.
●
Non-Responder Imputation (NRI)
●
Last Observation Carried Forward (LOCF)


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In case of an interim analysis, NRI and LOCF will be used.  Values will be imputed until 
that visit that the subject could have reached based on the cutoff date.
Section 7.1
First bullet previously read:
●
Subject demographics
○
Age (years) 
○
Age categories (< 40, 40 – 64, ≥ 65 years) 
○
Age (< 30, ≥ 30 to < 50, ≥ 50 years)
○
Gender (male/female)
○
Race (white, black, Asian, American Indian/Alaska native, native 
Hawaiian or other Pacific islander, other)
○
Ethnicity (Hispanic or Latino, no ethnicity)
○
Asian race (Chinese, Japanese, Korean, Taiwanese, Singaporean, 
Malaysian, other) (only for subjects from Japan)
Has been changed to read:
●
Subject demographics
○
Age (years) 
○
Age categories 1 (< 40, 40 – 64, ≥ 65 years) 
○
Age categories 2 (< 30, ≥30 to < 50, ≥ 50 years)
○
Gender (male/female)
○
Race (white, black, Asian, American Indian/Alaska native, native 
Hawaiian or other Pacific islander, other)
○
Ethnicity (Hispanic or Latino, no ethnicity)
○
Asian race (Chinese, Japanese, Korean, Taiwanese, Singaporean, 
Malaysian, other) (only for subjects from Japan)


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Section 7.5
First and second bullet previously read:
●
Immunosuppressants (IMMs) at baseline
○
Azathioprine
○
Cyclosporine
○
Methotrexate (MTX)
○
Mycophenolate mofetil or equivalent drug (e.g. mycophenolic acid)
○
Tacrolimus
●
Corticosteroids
○
Oral corticosteroids
○
Topical corticosteroids
○
Other corticosteroids
Has been changed to read:
●
Immunosuppressants (IMMs) 
○
Azathioprine
○
Cyclosporine
○
Methotrexate (MTX)
○
Mycophenolate mofetil or equivalent drug (e.g. mycophenolic acid)
○
Tacrolimus
●
Corticosteroids (CS)
○
Oral corticosteroids
○
Topical corticosteroids
○
Other corticosteroids


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Section 8.0
First paragraph previously read:
The number of subjects in each of the following categories will be summarized.  The 
subsequently described analyses will be provided by country as well as by investigator 
and overall.  Additionally, tables will be stratified by the parent study, 
Study M10-877/M10-880:
●
Subjects who received at least one dose of study medication (safety set)
●
Subjects who received at least one dose of study medication (ITT set)
●
Subjects who completed (safety set)
●
Subjects who prematurely discontinued (safety set)
Has been changed to read:
The number of subjects in each of the following categories will be summarized.  The 
subsequently described analyses will be provided by country as well as by investigator 
and overall.  Additionally, tables will be stratified by the parent study, 
Study M10-877/M10-880:
●
Subjects who received at least one dose of study medication (safety set)
●
Subjects who received at least one dose of study medication (ITT set)
●
Subjects who completed (safety set)
●
Subjects who prematurely discontinued (safety set)
●
Subjects who are ongoing (safety set, in case of an interim analysis)


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Section 10.1
Section previously read:
The subsequently described analyses will be provided in the ITT set.  All statistical 
analyses will be descriptive.  Results will be stratified between subjects who entered into 
the study with active versus inactive uveitis.  For subjects who had active uveitis when 
they entered the study, the efficacy analyses will start at Week 8 of Study M11-327.  For 
subjects who had inactive uveitis when they entered the study, the efficacy analyses will 
start at Baseline of Study M11-327.
Has been changed to read:
The subsequently described analyses will be provided in the ITT set.  All statistical 
analyses will be descriptive.  Results will be stratified between subjects who entered into 
the study with active versus inactive uveitis.  For subjects who had inactive and subjects 
who had active uveitis when they entered the study, the efficacy analyses will start at 
Baseline of Study M11-327.  Results will also be provided overall except for efficacy 
variables defined differently for subjects entering Study M11-327 with active and inactive 
uveitis. 
Section 10.2
First paragraph previously read:
The following efficacy variables will be analyzed:
●
Proportion of subjects at each study time point with no new active, 
inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes 
relative to Baseline for subjects who had inactive uveitis when they entered the 
study and to Week 8 for subjects who had active uveitis when they entered the 
study.


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●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in AC cells 
in both eyes on Slit Lamp Exam, according to SUN criteria.
●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in vitreous 
haze in both eyes on indirect ophthalmoscopy, according to NEI/SUN criteria.
●
Proportion of subjects at each study time point without a worsening of BCVA 
by ≥ 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in 
both eyes relative to Baseline for subjects who had inactive uveitis when they 
entered the study and to Week 8 for subjects who had active uveitis when they 
entered the study.
●
Percent change in central retinal thickness (1 mm subfield) in each eye at each 
study time point relative to Baseline for subjects who had inactive uveitis 
when they entered the study and to Week 8 for subjects who had active uveitis 
when they entered the study.
●
Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each 
study time point relative to Baseline for subjects who had inactive uveitis 
when they entered the study and to Week 8 for subjects who had active uveitis 
when they entered the study.
●
Proportion of subjects at each study time point achieving a ≥ 50% reduction in 
immunosuppression load relative to Baseline for subjects who had inactive 
uveitis when they entered the study and to Week 8 for subjects who had active 
uveitis when they entered the study.
Has been changed to read:
The following efficacy variables will be analyzed:
●
Proportion of subjects with no active lesions in both eyes at each study time 
point.
●
Proportion of subjects at each study time point with no new active, 
inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes 
relative to Baseline for subjects who had inactive uveitis when they entered the 
study and to Week 8 for subjects who had active uveitis when they entered the 
study.


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●
AC cell grade left/right eye and mean of both eyes at each study time point.
●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in AC cells 
in both eyes on Slit Lamp Exam, according to SUN criteria.
●
VH grades left/right eye and mean of both eyes at each study time point.
●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in vitreous 
haze in both eyes on indirect ophthalmoscopy, according to NEI/SUN criteria.
●
Proportion of subjects at each study time point with VH ≤ 0.5 and AC ≤ 0.5.
●
Proportion of subjects at each study time point with new lesions, AC ≥ 2 or 
VH ≥ 2.
●
Proportion of subjects at each study time point in quiescence defined as no 
active lesions, AC ≤ 0.5 and VH ≤ 0.5.
●
Proportion of subjects who experienced a uveitis flare (defined as no 
quiescence) during the study and who did or did not discontinue from the 
study due to the flare.
●
LogMAR Best corrected visual acuity (BCVA) left/right eye and mean of both 
eyes at each study time point.
●
Proportion of subjects at each study time point without a worsening of BCVA 
by ≥ 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in 
both eyes relative to Baseline for subjects who had inactive uveitis when they 
entered the study and to Week 8 for subjects who had active uveitis when they 
entered the study.
●
Proportion of subjects who started IMMs in Study M11-327.
●
Proportion of subjects on/off IMMs at each study time point only in subjects 
on IMMs at baseline of Study M11-327.
●
Proportion of subjects at each study time point achieving a ≥ 50% reduction in 
immunosuppression load relative to Baseline for subjects who had inactive 
uveitis when they entered the study and to Week 8 for subjects who had active 
uveitis when they entered the study.
●
Change in dose of IMM at each study time point relative to baseline for 
subjects who had inactive uveitis when they entered the study and to Week 8 
for subjects who had active uveitis when they entered the study only in 
subjects on IMMs at baseline/Week 8 of Study M11-327.


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●
Proportion of subjects who started systemic CS in Study M11-327.
●
Systemic CS dose at each study time point.
●
Proportion of subjects at each study time point with 
o
Systemic CS dose = 0 mg/day
o
Systemic CS dose > 0 to ≤ 5 mg/day
o
Systemic CS dose > 5 to ≤ 7.5 mg/day
o
Systemic CS dose > 7.5 to ≤ 10 mg/day 
o
Systemic CS dose > 10 to ≤ 20 mg/day
o
Systemic CS dose > 20 mg/day
●
Percent change in systemic CS dose at each study time point relative to 
baseline only in subjects on CS at baseline.
●
Proportion of subjects in steroid-free quiescence at each study time point.
●
Proportion of subjects in quiescence and for subjects without quiescence the 
proportion of subjects
o
with/without a change in concomitant medication (topical/systemic 
corticosteroids, immunosuppressants) within 5 days after non-quiescence 
and with/without quiescence at the next visit (at least 8 Weeks after 
non-quiescence)
o
with premature discontinuation
●
OCT evidence of macular edema in at least one eye at each study time point.
●
Central retinal thickness left/right eye and mean of both eyes at each study 
time point by OCT machine.
●
Percent change in central retinal thickness (1 mm subfield) in each eye at each 
study time point relative to Baseline for subjects who had inactive uveitis 
when they entered the study and to Week 8 for subjects who had active uveitis 
when they entered the study.
●
Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each 
study time point relative to Baseline for subjects who had inactive uveitis 
when they entered the study and to Week 8 for subjects who had active uveitis 
when they entered the study.


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Last paragraph previously read:
The efficacy variables will be analyzed as follows.
Descriptive statistics for quantitative variables will include the number of observations, 
mean, standard deviation, minimum, first quartile, median, third quartile, and maximum 
for values at each visit, changes from Baseline/Week 8 to each visit thereafter and change 
from Baseline/Week 8 to Final/Early Termination Visit for continuous variables.  In 
addition, for central retinal thickness percent change from Baseline/Week 8 to each visit 
thereafter and percent change from Baseline/Week 8 to Final/Early Termination Visit will 
be analyzed.  For central retinal thickness, values at each visit and changes will be 
analyzed by OCT machine, percent changes will be analyzed overall.  Data will be 
analyzed by Last Observation Carried Forward (LOCF) and as observed.  Categorical 
variables will be summarized by counts and percentages at each visit.  Data will be 
analyzed by Non Responder Imputation (NRI) and as observed.
Has been changed to read:
The efficacy variables will be analyzed as follows.
Descriptive statistics for quantitative variables will include the number of observations, 
mean, standard deviation, minimum, first quartile, median, third quartile, and maximum 
for values at each visit, changes from Baseline/Week 8 to each visit thereafter and change 
from Baseline/Week 8 to Final/Early Termination Visit for continuous variables.  In 
addition, for central retinal thickness percent change from Baseline/Week 8 to each visit 
thereafter and percent change from Baseline/Week 8 to Final/Early Termination Visit will 
be analyzed.  For central retinal thickness, values at each visit and changes will be 
analyzed by OCT machine, percent changes will be analyzed overall.  95% confidence 
intervals for means will be provided.  Data will be analyzed by Last Observation Carried 
Forward (LOCF) and as observed.  For as observed analyses, graphs will be generated for 
subjects with active vs. inactive uveitis at entry of Study M11-327 for:


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●
LogMAR Best corrected visual acuity (BCVA) (mean of both eyes) at each 
study time point.
●
Systemic CS dose at each study time point.
●
Central retinal thickness (mean of both eyes) at each study time point by OCT 
machine.
Categorical variables will be summarized by counts and percentages at each visit.  
95% confidence intervals for proportions will be provided.  Data will be analyzed by Non 
Responder Imputation (NRI) and as observed.  For as observed analyses, graphs will be 
generated for subjects with active vs. inactive uveitis at entry of Study M11-327 for: 
●
Proportion of subjects with no active lesions in both eyes at each study time 
point.
●
Proportion of subjects at each study time point with a Grade ≤ 0.5+ in AC cells 
in both eyes on Slit Lamp Exam, according to SUN criteria.
●
Proportion of subjects at each study time point with Grade ≤ 0.5+ in vitreous 
haze in both eyes on indirect ophthalmoscopy, according to NEI/SUN criteria.
●
Proportion of subjects at each study time point in quiescence defined as no 
active lesions, AC ≤ 0.5 and VH ≤ 0.5.
●
Proportion of subjects with steroid-free quiescence at each study time point.
●
OCT evidence of macular edema in at least one eye at each study time point.
Section 10.4
First paragraph previously read:
The efficacy variables from Section 10.2 will be analyzed as described in Section 10.2 in 
the following subgroups:
●
IMM usage at Baseline of Study M11-327 (yes, no)


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Has been changed to read:
The following efficacy variables will be analyzed as described in Section 10.2 by pooling 
subjects with active and inactive uveitis at start of Study M11-327
●
Proportion of subjects with no active lesions in both eyes at each study time 
point.
●
AC cell grade (mean of both eyes) at each study time point.
●
Proportion of subjects with a Grade ≤ 0.5+ in AC cells in both eyes on Slit 
Lamp Exam, according to SUN criteria at each study time point.
●
VH grades (mean of both eyes) at each study time point.
●
Proportion of subjects at each study time point with Grade ≤ 0.5+ in vitreous 
haze in both eyes on indirect ophthalmoscopy, according to NEI/SUN criteria.
●
Proportion of subjects at each study time point in quiescence defined as no 
active lesions, AC ≤ 0.5 and VH ≤ 0.5.
●
LogMAR Best corrected visual acuity (BCVA) (mean of both eyes) at each 
study time point.
●
Proportion of subjects who started IMMs in Study M11-327.
●
Systemic CS dose at each study time point.
●
Proportion of subjects with steroid-free quiescence at each study time point.
●
OCT evidence of macular edema in at least one eye at each study time point.
●
Central retinal thickness (mean of both eyes) at each study time point by OCT 
machine.
in the following subgroups:
●
Gender (male/female)
●
Duration of uveitis (< 1, ≥ 1 years)
●
Type of uveitis (intermediate versus posterior versus panuveitis)
●
Diagnosis (idiopathic/other versus birdshot choroidopathy versus multifocal 
choroiditis and panuveitis versus Vogt Koyanagi Harada versus sarcoid versus 
Behcet's)


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●
IMM usage at Baseline of Study M11-327 (yes, no)
Section 11.1 
Last paragraph previously read:
Analyses of AEs per subgroup will be presented for the AE overview.  The number and 
percentage of subjects experiencing AEs will be tabulated overall. 
Subgroups used for the analyses are:
●
Concomitant use of corticosteroids (yes, no)
●
Baseline immunosuppressant usage (yes, no)
●
Baseline azathioprine usage
●
Baseline cyclosporine usage
●
Baseline methotrexate usage
●
Baseline mycophenolate mofetil or an equivalent drug (e.g., mycophenolic 
acid) usage
●
Baseline tacrolimus usage
Has been changed to read:
Analyses of AEs per subgroup will be presented for the AE overview.  The number and 
percentage of subjects experiencing AEs as well as E/100PYs will be tabulated overall. 
Subgroups used for the analyses are:
●
Concomitant use of corticosteroids (yes, no)
●
Baseline immunosuppressant usage (yes, no)
●
Baseline azathioprine usage
●
Baseline cyclosporine usage
●
Baseline methotrexate usage


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●
Baseline mycophenolate mofetil or an equivalent drug (e.g., mycophenolic 
acid) usage
●
Baseline tacrolimus usage
An AE overview (with number and percentage of subjects experiencing 
treatment-emergent AEs as well as E/100PYs) will also be presented separately for
●
treatment periods with/without concomitant use of corticosteroids
●
treatment periods with corticosteroid dose > 0 to ≤ 15 mg/day
●
treatment periods with corticosteroid dose > 15 mg/day
●
treatment periods with/without concomitant use of immunosuppressant
●
treatment periods
○
without concomitant use of corticosteroids and immunosuppressant
○
with concomitant use of corticosteroids only
○
with concomitant use of immunosuppressant only
○
with concomitant use of corticosteroids and immunosuppressant