Trial Outcomes & Findings for A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy (NCT NCT01287897)
NCT ID: NCT01287897
Last Updated: 2016-01-21
Results Overview
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (\>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2016-01-21
Participant Flow
This study included a 28-day screening period, an induction period (Week 0-12) and a 28-week follow-up period. Participants who completed the induction treatment period could enter the follow-up period or an open-label extension study, NCT01345318. Participants who discontinued treatment during the induction period could enter the follow-up period.
A total of 250 participants were randomized via Interactive Voice Response System (IVRS); of which, 247 received investigational product and 3 were randomized inadvertently and not dosed (2 did not meet entrance criteria and 1 did not consent properly and was not included in clinical database because the randomization page was not completed).
Participant milestones
| Measure |
Placebo
Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 Milligram (mg)
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
71
|
40
|
|
Overall Study
Treated
|
69
|
67
|
71
|
40
|
|
Overall Study
Completed Treatment Period
|
58
|
52
|
58
|
29
|
|
Overall Study
Completed Follow-up Period
|
3
|
8
|
3
|
4
|
|
Overall Study
Enrolled in NCT01345318
|
56
|
50
|
56
|
29
|
|
Overall Study
COMPLETED
|
59
|
58
|
59
|
33
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
12
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 Milligram (mg)
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
6
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
3
|
2
|
|
Overall Study
Not consented properly
|
0
|
1
|
0
|
0
|
|
Overall Study
Not meeting entrance criteria
|
1
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=67 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
n=40 Participants
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.4 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
38.9 Years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
38.9 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
42.2 Years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
39.3 Years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Primary analysis: full analysis set (FAS, defined as all randomized participants who received at least 1 dose of study treatment; 2 participants \[10 mg arm\] excluded due to a quality issue) excluding 200 mg (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (\>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=65 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
|
30.6 Percentage of participants
Interval 18.7 to 45.9
|
35.0 Percentage of participants
Interval 21.6 to 51.1
|
49.3 Percentage of participants
Interval 34.1 to 64.7
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: The analysis was performed on FAS participants of the 200 mg and placebo arms, referred to as FAS 200 mg versus (vs) placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=40 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
|
28.8 Percentage of participants
Interval 15.4 to 47.4
|
39.0 Percentage of participants
Interval 19.3 to 63.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Primary analysis: FAS excluding 200 mg arm (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=65 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
|
28.6 Percentage of participants
Interval 17.1 to 43.7
|
35.2 Percentage of participants
Interval 21.8 to 51.5
|
47.4 Percentage of participants
Interval 32.1 to 63.1
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The analysis was performed on FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=40 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
|
26.7 Percentage of participants
Interval 14.0 to 44.9
|
41.7 Percentage of participants
Interval 21.2 to 65.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, and 10Population: The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=65 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 2 (n=64, 63, 65)
|
12.3 Percentage of participants
Interval 6.3 to 22.6
|
19.4 Percentage of participants
Interval 10.9 to 32.2
|
18.1 Percentage of participants
Interval 10.1 to 30.3
|
—
|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 4 (n=66, 58, 59)
|
16.5 Percentage of participants
Interval 9.0 to 28.2
|
34.6 Percentage of participants
Interval 21.7 to 50.3
|
37.0 Percentage of participants
Interval 23.8 to 52.5
|
—
|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 6 (n=58, 53, 60)
|
21.1 Percentage of participants
Interval 11.9 to 34.6
|
35.0 Percentage of participants
Interval 21.7 to 51.2
|
46.2 Percentage of participants
Interval 31.6 to 61.5
|
—
|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 10 (n=54, 50, 51)
|
29.3 Percentage of participants
Interval 17.5 to 44.7
|
38.9 Percentage of participants
Interval 24.4 to 55.5
|
54.0 Percentage of participants
Interval 37.8 to 69.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, and 10Population: The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=40 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 2 (n=64, 36)
|
11.2 Percentage of participants
Interval 5.0 to 23.1
|
26.5 Percentage of participants
Interval 12.3 to 48.2
|
—
|
—
|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 4 (n=66, 35)
|
15.2 Percentage of participants
Interval 7.2 to 29.1
|
24.6 Percentage of participants
Interval 11.2 to 45.9
|
—
|
—
|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 6 (n=58, 32)
|
19.5 Percentage of participants
Interval 9.6 to 35.6
|
27.2 Percentage of participants
Interval 12.4 to 49.8
|
—
|
—
|
|
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 10 (n=54, 29)
|
27.2 Percentage of participants
Interval 14.2 to 45.8
|
46.3 Percentage of participants
Interval 24.5 to 69.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, and 12Population: The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI remission rate was defined as an absolute CDAI score less than (\<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=65 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 12 (n=57, 52, 57)
|
10.9 Percentage of participants
Interval 4.5 to 24.1
|
10.8 Percentage of participants
Interval 4.4 to 24.5
|
27.4 Percentage of participants
Interval 14.9 to 44.9
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 2 (n=64, 63, 68)
|
1.6 Percentage of participants
Interval 0.3 to 9.1
|
3.6 Percentage of participants
Interval 1.0 to 12.3
|
9.6 Percentage of participants
Interval 4.1 to 20.7
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 4 (n=66, 58, 62)
|
3.4 Percentage of participants
Interval 0.9 to 11.6
|
4.1 Percentage of participants
Interval 1.1 to 13.6
|
19.7 Percentage of participants
Interval 10.0 to 35.1
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 6 (n=58, 53, 63)
|
8.5 Percentage of participants
Interval 3.3 to 20.3
|
7.3 Percentage of participants
Interval 2.6 to 19.2
|
23.4 Percentage of participants
Interval 12.5 to 39.6
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 8 (n=58, 53, 58)
|
16.3 Percentage of participants
Interval 7.6 to 31.7
|
10.8 Percentage of participants
Interval 4.4 to 24.4
|
24.9 Percentage of participants
Interval 13.3 to 41.7
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 10 (n=54, 50, 54)
|
13.1 Percentage of participants
Interval 5.6 to 27.7
|
19.9 Percentage of participants
Interval 9.4 to 37.2
|
30.9 Percentage of participants
Interval 17.2 to 49.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, and 12Population: The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI remission rate was defined as an absolute CDAI score \<150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=40 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 2 (n=64, 36)
|
1.1 Percentage of participants
Interval 0.2 to 7.2
|
6.9 Percentage of participants
Interval 1.8 to 23.1
|
—
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 4 (n=66, 35)
|
2.4 Percentage of participants
Interval 0.5 to 9.8
|
5.1 Percentage of participants
Interval 1.2 to 19.6
|
—
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 6 (n=58, 32)
|
6.1 Percentage of participants
Interval 1.9 to 18.1
|
8.8 Percentage of participants
Interval 2.4 to 27.6
|
—
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 8 (n=58, 29)
|
11.9 Percentage of participants
Interval 4.3 to 29.1
|
8.8 Percentage of participants
Interval 2.3 to 28.3
|
—
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 10 (n=54, 29)
|
9.4 Percentage of participants
Interval 3.2 to 24.9
|
14.8 Percentage of participants
Interval 4.6 to 38.5
|
—
|
—
|
|
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 12 (n=57, 29)
|
7.8 Percentage of participants
Interval 2.5 to 21.5
|
11.8 Percentage of participants
Interval 3.4 to 33.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, and 12Population: The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=65 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 2 (n=64, 63, 65)
|
12.4 Percentage of participants
Interval 6.1 to 23.7
|
16.7 Percentage of participants
Interval 8.8 to 29.7
|
12.6 Percentage of participants
Interval 6.2 to 24.0
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 4 (n=66, 58, 59)
|
13.0 Percentage of participants
Interval 6.5 to 24.4
|
18.1 Percentage of participants
Interval 9.5 to 31.9
|
26.3 Percentage of participants
Interval 15.1 to 41.8
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 6 (n=58, 53, 60)
|
14.5 Percentage of participants
Interval 7.2 to 26.9
|
28.7 Percentage of participants
Interval 16.4 to 45.1
|
32.2 Percentage of participants
Interval 19.5 to 48.2
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 8 (n=58, 53, 56)
|
24.1 Percentage of participants
Interval 13.4 to 39.3
|
26.5 Percentage of participants
Interval 14.9 to 42.6
|
37.9 Percentage of participants
Interval 23.7 to 54.5
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 10 (n=54, 50, 51)
|
21.0 Percentage of participants
Interval 11.2 to 35.8
|
29.8 Percentage of participants
Interval 17.0 to 46.8
|
38.2 Percentage of participants
Interval 23.6 to 55.3
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 12 (n=57, 52, 54)
|
22.2 Percentage of participants
Interval 12.1 to 37.0
|
32.7 Percentage of participants
Interval 19.2 to 49.7
|
36.2 Percentage of participants
Interval 22.2 to 52.9
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, and 12Population: The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=40 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 2 (n=64, 36)
|
10.3 Percentage of participants
Interval 4.4 to 22.6
|
12.0 Percentage of participants
Interval 4.5 to 28.6
|
—
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 4 (n=66, 35)
|
11.0 Percentage of participants
Interval 4.7 to 23.5
|
22.1 Percentage of participants
Interval 9.5 to 43.5
|
—
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 6 (n=58, 32)
|
12.2 Percentage of participants
Interval 5.3 to 25.8
|
22.2 Percentage of participants
Interval 9.3 to 44.2
|
—
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 8 (n=58, 29)
|
21.3 Percentage of participants
Interval 10.3 to 39.1
|
18.7 Percentage of participants
Interval 7.3 to 40.2
|
—
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 10 (n=54, 29)
|
18.2 Percentage of participants
Interval 8.4 to 34.9
|
30.4 Percentage of participants
Interval 13.6 to 54.8
|
—
|
—
|
|
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 12 (n=57, 29)
|
19.4 Percentage of participants
Interval 9.2 to 36.5
|
26.9 Percentage of participants
Interval 11.6 to 50.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, and 12Population: The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=65 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 2 (n=64, 63, 65)
|
-18.9 points on a scale
Interval -38.3 to 0.6
|
-28.4 points on a scale
Interval -47.6 to -9.3
|
-16.2 points on a scale
Interval -34.5 to 2.2
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 4 (n=66, 58, 59)
|
-25.1 points on a scale
Interval -44.9 to -5.2
|
-37.1 points on a scale
Interval -57.0 to -17.1
|
-50.7 points on a scale
Interval -70.0 to -31.5
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 6 (n=58, 53, 60)
|
-32.6 points on a scale
Interval -55.5 to -9.6
|
-48.5 points on a scale
Interval -71.7 to -25.3
|
-54.9 points on a scale
Interval -77.0 to -32.9
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 8 (n=58, 53, 56)
|
-34.6 points on a scale
Interval -58.8 to -10.5
|
-49.6 points on a scale
Interval -74.1 to -25.0
|
-63.5 points on a scale
Interval -86.9 to -40.0
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 10 (n=54, 50, 51)
|
-19.8 points on a scale
Interval -45.9 to 6.4
|
-50.0 points on a scale
Interval -76.6 to -23.4
|
-64.7 points on a scale
Interval -90.3 to -39.1
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Week 12 (n=57, 52, 54)
|
-27.3 points on a scale
Interval -53.5 to -1.2
|
-44.2 points on a scale
Interval -70.9 to -17.5
|
-66.8 points on a scale
Interval -92.5 to -41.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, and 12Population: The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. "n" signifies the number of subjects with observed data of each arm at each time point.
CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=40 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 2 (n=64, 36)
|
-21.3 points on a scale
Interval -49.1 to 6.6
|
-30.1 points on a scale
Interval -62.2 to 2.1
|
—
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 4 (n=66, 35)
|
-26.6 points on a scale
Interval -54.3 to 1.1
|
-30.5 points on a scale
Interval -62.5 to 1.6
|
—
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 6 (n=58, 32)
|
-36.7 points on a scale
Interval -64.6 to -8.7
|
-42.2 points on a scale
Interval -74.8 to -9.6
|
—
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 8 (n=58, 29)
|
-39.1 points on a scale
Interval -67.2 to -11.0
|
-48.1 points on a scale
Interval -81.3 to -14.9
|
—
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 10 (n=54, 29)
|
-26.3 points on a scale
Interval -54.7 to 2.1
|
-56.1 points on a scale
Interval -89.5 to -22.7
|
—
|
—
|
|
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Week 12 (n=57, 29)
|
-35.2 points on a scale
Interval -63.6 to -6.8
|
-66.2 points on a scale
Interval -99.9 to -32.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40Population: The SAS consisted of all participants who received at least 1 dose of study drug. "n" signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed.
The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) \>= 4.32.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=71 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=40 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Day 1 (n=56, 66, 36)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Week 4 (n=58, 62, 29)
|
0.0 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Week 8 (n=53, 53, 27)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Week 12 (n=46, 49, 24)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Week 16 (n=2, 1, 0)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
—
|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Week 24 (n=2, 1, 0)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
—
|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Week 32 (n=1, 0, 0)
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
NA percentage of participants
No participants analyzed.
|
—
|
|
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Week 40 (n=2, 1, 0)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
—
|
SECONDARY outcome
Timeframe: At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40Population: The SAS consisted of all participants who received at least 1 dose of study drug. "n" signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed.
The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=71 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=40 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Week 32 (n=1, 0, 0)
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
NA percentage of participants
No participants analyzed.
|
—
|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Week 40 (n=2, 1, 0)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
—
|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Day 1 (n=56, 66, 36)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Week 4 (n=58, 62, 29)
|
0.0 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Week 8 (n=53, 53, 27)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Week 12 (n=46, 49, 24)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Week 16 (n=2, 1, 0)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
—
|
|
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Week 24 (n=2, 1, 0)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
NA percentage of participants
No participants analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40Population: The pharmacokinetic (PK) analysis set was the subset of participants from the SAS who provided at least 1 PK concentration (2 participants \[10 mg arm\] excluded due to a quality issue). "n" is the number of participants with PK data at the visit. From Weeks 16 to 40, only participants who remained in the follow-up period of this study were analyzed.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=71 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=40 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Serum PF-04236921 Concentration Over Time
Day 1 (n=54, 64, 37)
|
4.52 nanogram per milliliter (ng/mL)
Standard Deviation 33.20
|
2.05 nanogram per milliliter (ng/mL)
Standard Deviation 16.38
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Concentrations were not determined due to being below the lower limit of quantification (\<LLOQ)
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 2 (n=46, 56, 30)
|
1060 nanogram per milliliter (ng/mL)
Standard Deviation 531.3
|
4580 nanogram per milliliter (ng/mL)
Standard Deviation 1938
|
21300 nanogram per milliliter (ng/mL)
Standard Deviation 9547
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 4 (n=56, 63, 29)
|
674 nanogram per milliliter (ng/mL)
Standard Deviation 339.3
|
3180 nanogram per milliliter (ng/mL)
Standard Deviation 1555
|
14800 nanogram per milliliter (ng/mL)
Standard Deviation 6641
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 6 (n=48, 57, 28)
|
1470 nanogram per milliliter (ng/mL)
Standard Deviation 863.0
|
6610 nanogram per milliliter (ng/mL)
Standard Deviation 2668
|
32200 nanogram per milliliter (ng/mL)
Standard Deviation 13240
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 8 (n=51, 52, 28)
|
992 nanogram per milliliter (ng/mL)
Standard Deviation 501.7
|
4500 nanogram per milliliter (ng/mL)
Standard Deviation 1993
|
20200 nanogram per milliliter (ng/mL)
Standard Deviation 8683
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 10 (n=47, 54, 29)
|
695 nanogram per milliliter (ng/mL)
Standard Deviation 428.5
|
3280 nanogram per milliliter (ng/mL)
Standard Deviation 1961
|
13600 nanogram per milliliter (ng/mL)
Standard Deviation 7350
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 12 (n=43, 51, 26)
|
504 nanogram per milliliter (ng/mL)
Standard Deviation 435.5
|
2110 nanogram per milliliter (ng/mL)
Standard Deviation 1333
|
10900 nanogram per milliliter (ng/mL)
Standard Deviation 7802
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 16 (n=2, 1, 0)
|
177 nanogram per milliliter (ng/mL)
Standard Deviation 250.3
|
1290 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not calculable as there was only 1 participant.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 20 (n=2, 1, 0)
|
102 nanogram per milliliter (ng/mL)
Standard Deviation 143.5
|
425 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not calculable as there was only 1 participant.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 24 (n=2, 1, 0)
|
63.5 nanogram per milliliter (ng/mL)
Standard Deviation 89.80
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Concentrations were not determined due to \<LLOQ
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 28 (n=2, 0, 0)
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Concentrations were not determined due to \<LLOQ
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 32 (n=2, 0, 0)
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Concentrations were not determined due to \<LLOQ
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 36 (n=2, 1, 0)
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Concentrations were not determined due to \<LLOQ
|
109 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not calculable as there was only 1 participant.
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
—
|
|
Serum PF-04236921 Concentration Over Time
Week 40 (n=2, 1, 0)
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Concentrations were not determined due to \<LLOQ
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Concentrations were not determined due to \<LLOQ
|
NA nanogram per milliliter (ng/mL)
Standard Deviation NA
Number of participants analyzed was 0 at the visit
|
—
|
SECONDARY outcome
Timeframe: Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)Population: The SAS consisted of all participants who received at least 1 dose of study drug. "n" signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed.
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=69 Participants
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=67 Participants
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 Participants
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
n=40 Participants
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)
Induction period (Weeks 0 to 12)
|
7 participants
|
6 participants
|
6 participants
|
8 participants
|
|
Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)
Follow-up period (after Week 12)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Placebo
Serious events: 11 serious events
Other events: 36 other events
Deaths: 0 deaths
PF-04236921 10 mg
Serious events: 11 serious events
Other events: 38 other events
Deaths: 0 deaths
PF-04236921 50 mg
Serious events: 12 serious events
Other events: 48 other events
Deaths: 0 deaths
PF-04236921 200 mg
Serious events: 11 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=69 participants at risk
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=67 participants at risk
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 participants at risk
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
n=40 participants at risk
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
3.0%
2/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.8%
2/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
8.7%
6/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.0%
6/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
5/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
10.0%
4/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ileal fistula
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Device occlusion
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Malaise
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abscess
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.8%
2/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sepsis
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
VIIth nerve paralysis
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=69 participants at risk
Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 10 mg
n=67 participants at risk
PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 50 mg
n=71 participants at risk
PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
PF-04236921 200 mg
n=40 participants at risk
PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.8%
4/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.8%
2/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
5.0%
2/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.6%
8/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.0%
6/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
11.3%
8/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
15.0%
6/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.5%
3/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
5.8%
4/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
3.0%
2/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.9%
7/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
10.0%
4/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
11.9%
8/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.9%
7/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
3.0%
2/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
5/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
6.0%
4/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
5/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
5.0%
2/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
3.0%
2/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
5.6%
4/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
10.1%
7/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.5%
5/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
5/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
3/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.4%
11/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
11.3%
8/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.5%
3/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
2/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
5.6%
4/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
3/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
6.0%
4/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.2%
3/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
12.5%
5/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.6%
8/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.5%
5/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
5/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
4/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
6.0%
4/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.2%
3/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
4/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
3.0%
2/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.4%
1/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
8.7%
6/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
6.0%
4/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
12.7%
9/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
5.0%
2/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
1.5%
1/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
5/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/69 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.5%
3/67 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.9%
7/71 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.5%
1/40 • The reporting period was from the time of the first dose of study treatment through last subject visit up to 40 weeks post the first dose of study treatment for serious adverse events (SAEs) and other adverse events (AEs).
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigators will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER