Trial Outcomes & Findings for A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy (NCT NCT02365649)
NCT ID: NCT02365649
Last Updated: 2023-12-27
Results Overview
Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
220 participants
Primary outcome timeframe
Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)
Results posted on
2023-12-27
Participant Flow
Participant milestones
| Measure |
Double-Blind Induction Phase: Placebo BID
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Double Blind Extension Phase: Upadacitinib 3 mg BID
Upadacitinib 3 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: Upadacitinib 6 mg BID
Upadacitinib 6 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: Upadacitinib 12 mg BID
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Induction (Weeks 1-16)
STARTED
|
37
|
39
|
37
|
36
|
36
|
35
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
COMPLETED
|
27
|
34
|
33
|
27
|
29
|
30
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
NOT COMPLETED
|
10
|
5
|
4
|
9
|
7
|
5
|
0
|
0
|
0
|
0
|
|
Double-Blind Extension (Weeks 16-52)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
61
|
23
|
59
|
37
|
|
Double-Blind Extension (Weeks 16-52)
Switched to OL 12 mg BID
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
5
|
17
|
17
|
|
Double-Blind Extension (Weeks 16-52)
Further Dose Escalated to OL 24 mg BID
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
10
|
10
|
|
Double-Blind Extension (Weeks 16-52)
Dose De-escalated to OL 12 mg BID
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Extension (Weeks 16-52)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
43
|
21
|
43
|
22
|
|
Double-Blind Extension (Weeks 16-52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
2
|
16
|
15
|
Reasons for withdrawal
| Measure |
Double-Blind Induction Phase: Placebo BID
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Double Blind Extension Phase: Upadacitinib 3 mg BID
Upadacitinib 3 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: Upadacitinib 6 mg BID
Upadacitinib 6 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: Upadacitinib 12 mg BID
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double-Blind Induction (Weeks 1-16)
Requires alternative therapy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
Adverse Event
|
3
|
4
|
0
|
7
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
Lack of Efficacy
|
3
|
1
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
Other
|
1
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
Subject Non-Compliance
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction (Weeks 1-16)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Extension (Weeks 16-52)
Requires Alternative Therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Double-Blind Extension (Weeks 16-52)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
4
|
4
|
|
Double-Blind Extension (Weeks 16-52)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
2
|
8
|
10
|
|
Double-Blind Extension (Weeks 16-52)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
|
Double-Blind Extension (Weeks 16-52)
Subject Noncompliance
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
0
|
Baseline Characteristics
participants with an assessment at baseline
Baseline characteristics by cohort
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 12.14 • n=37 Participants
|
39.7 years
STANDARD_DEVIATION 14.03 • n=39 Participants
|
40.5 years
STANDARD_DEVIATION 13.41 • n=37 Participants
|
40.8 years
STANDARD_DEVIATION 15.18 • n=36 Participants
|
42.5 years
STANDARD_DEVIATION 10.02 • n=36 Participants
|
40.2 years
STANDARD_DEVIATION 12.60 • n=35 Participants
|
40.7 years
STANDARD_DEVIATION 12.90 • n=220 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=37 Participants
|
19 Participants
n=39 Participants
|
21 Participants
n=37 Participants
|
17 Participants
n=36 Participants
|
25 Participants
n=36 Participants
|
19 Participants
n=35 Participants
|
125 Participants
n=220 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
20 Participants
n=39 Participants
|
16 Participants
n=37 Participants
|
19 Participants
n=36 Participants
|
11 Participants
n=36 Participants
|
16 Participants
n=35 Participants
|
95 Participants
n=220 Participants
|
|
High-sensitivity C-reactive protein (hsCRP)
|
20.8 mg/L
STANDARD_DEVIATION 34.29 • n=37 Participants
|
23.6 mg/L
STANDARD_DEVIATION 51.43 • n=39 Participants
|
17.9 mg/L
STANDARD_DEVIATION 17.92 • n=37 Participants
|
26.9 mg/L
STANDARD_DEVIATION 28.86 • n=36 Participants
|
17.1 mg/L
STANDARD_DEVIATION 26.49 • n=36 Participants
|
17.1 mg/L
STANDARD_DEVIATION 20.83 • n=35 Participants
|
20.6 mg/L
STANDARD_DEVIATION 32.11 • n=220 Participants
|
|
Fecal Calprotectin
|
1734.7 mcg/g
STANDARD_DEVIATION 2444.07 • n=31 Participants • participants with an assessment at baseline
|
1925.9 mcg/g
STANDARD_DEVIATION 2804.07 • n=33 Participants • participants with an assessment at baseline
|
2128.5 mcg/g
STANDARD_DEVIATION 1978.73 • n=36 Participants • participants with an assessment at baseline
|
2067.9 mcg/g
STANDARD_DEVIATION 2250.97 • n=33 Participants • participants with an assessment at baseline
|
2074.8 mcg/g
STANDARD_DEVIATION 2324.15 • n=29 Participants • participants with an assessment at baseline
|
1808.7 mcg/g
STANDARD_DEVIATION 2548.11 • n=31 Participants • participants with an assessment at baseline
|
1960.8 mcg/g
STANDARD_DEVIATION 2371.86 • n=193 Participants • participants with an assessment at baseline
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ)
|
118.0 units on a scale
STANDARD_DEVIATION 28.45 • n=37 Participants • participants with an assessment at baseline
|
115.2 units on a scale
STANDARD_DEVIATION 27.48 • n=38 Participants • participants with an assessment at baseline
|
113.7 units on a scale
STANDARD_DEVIATION 25.86 • n=36 Participants • participants with an assessment at baseline
|
115.2 units on a scale
STANDARD_DEVIATION 36.05 • n=35 Participants • participants with an assessment at baseline
|
113.8 units on a scale
STANDARD_DEVIATION 35.97 • n=36 Participants • participants with an assessment at baseline
|
120.7 units on a scale
STANDARD_DEVIATION 36.25 • n=34 Participants • participants with an assessment at baseline
|
116.1 units on a scale
STANDARD_DEVIATION 31.60 • n=216 Participants • participants with an assessment at baseline
|
PRIMARY outcome
Timeframe: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)Population: Modified intention to Treat (mITT) Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Endoscopic remission was determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Endoscopic Remission at Week 12/16
|
0 percentage of participants
|
10.3 percentage of participants
|
8.1 percentage of participants
|
8.3 percentage of participants
|
22.2 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Clinical Remission at Week 16
|
10.8 percentage of participants
|
12.8 percentage of participants
|
27.0 percentage of participants
|
11.1 percentage of participants
|
22.2 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) < 150 at Week 16
|
16.2 percentage of participants
|
20.5 percentage of participants
|
29.7 percentage of participants
|
38.9 percentage of participants
|
30.6 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Decrease in CDAI ≥ 70 Points From Baseline at Week 16
|
35.1 percentage of participants
|
46.2 percentage of participants
|
54.1 percentage of participants
|
44.4 percentage of participants
|
61.1 percentage of participants
|
48.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Clinical Remission at Week 12
|
10.8 percentage of participants
|
10.3 percentage of participants
|
29.7 percentage of participants
|
13.9 percentage of participants
|
25.0 percentage of participants
|
8.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Remission at Week 16
|
0.0 percentage of participants
|
2.6 percentage of participants
|
5.4 percentage of participants
|
2.8 percentage of participants
|
8.3 percentage of participants
|
5.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Response is defined as endoscopic response at Week 12/16 AND clinical response at Week 16. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Response at Week 16
|
2.7 percentage of participants
|
15.4 percentage of participants
|
32.4 percentage of participants
|
27.8 percentage of participants
|
38.9 percentage of participants
|
34.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16 (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)Population: mITT Population: all randomized subjects who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Endoscopic response: SES-CD at least 25% reduction from Baseline. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Endoscopic Response at Week 12/16
|
13.5 percentage of participants
|
23.1 percentage of participants
|
43.2 percentage of participants
|
36.1 percentage of participants
|
50.0 percentage of participants
|
48.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Clinical response: average daily stool frequency at least 30% reduction from Baseline and average daily abdominal pain not worse than Baseline OR average daily abdominal pain at least 30% reduction from Baseline and average daily stool frequency not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Clinical Response at Week 16
|
32.4 percentage of participants
|
43.6 percentage of participants
|
56.8 percentage of participants
|
47.2 percentage of participants
|
61.1 percentage of participants
|
48.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an average daily stool frequency ≥ 2.5 AND average daily abdominal pain ≥ 2.0 at Baseline. Non-responder imputation.
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=14 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=17 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=16 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=18 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=12 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=18 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Average Daily Stool Frequency ≥ 2.5 AND Average Daily Abdominal Pain ≥ 2.0 at Baseline Who Achieve Clinical Remission at Week 16
|
7.1 percentage of participants
|
17.6 percentage of participants
|
18.8 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
11.1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=15 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=21 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=18 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=17 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=15 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=10 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 at Week 16
|
0.0 percentage of participants
|
19.0 percentage of participants
|
22.2 percentage of participants
|
41.2 percentage of participants
|
33.3 percentage of participants
|
10.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16. (At Baseline, subjects were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
Remission is defined as endoscopic remission at Week 12/16 AND clinical remission at Week 16. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=15 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=21 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=18 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=17 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=15 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=10 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Remission at Week 12/16 and Clinical Remission at Week 16
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.6 percentage of participants
|
5.9 percentage of participants
|
13.3 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=15 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=21 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=18 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=17 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=15 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=10 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission at Week 16
|
0.0 percentage of participants
|
14.3 percentage of participants
|
22.2 percentage of participants
|
11.8 percentage of participants
|
33.3 percentage of participants
|
10.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants taking corticosteroids at Baseline. Non-responder imputation.
Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=15 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=21 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=18 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=17 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=15 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=10 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 12/16
|
0.0 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
5.9 percentage of participants
|
20.0 percentage of participants
|
10.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants with an assessment at Baseline and Week 16 and with an assessment at given time point.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=28 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=26 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=31 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=28 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=25 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=26 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase
Week 4
|
83.7 μg/g
Standard Deviation 1024.11
|
-310.3 μg/g
Standard Deviation 2415.43
|
-436.9 μg/g
Standard Deviation 1505.75
|
-915.7 μg/g
Standard Deviation 1600.31
|
-876.2 μg/g
Standard Deviation 2240.93
|
-255.8 μg/g
Standard Deviation 2407.47
|
—
|
—
|
|
Change From Baseline in Fecal Calprotectin Level Over Time During the Induction Phase
Week 16
|
-128.9 μg/g
Standard Deviation 373.53
|
-534.5 μg/g
Standard Deviation 3279.19
|
-429.4 μg/g
Standard Deviation 2505.21
|
-475.1 μg/g
Standard Deviation 2668.93
|
-828.7 μg/g
Standard Deviation 986.09
|
-698.4 μg/g
Standard Deviation 2228.85
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants with an assessment at Baseline and Week 16.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=29 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=35 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=34 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=31 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=27 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=32 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 16
|
-0.1 mg/L
Standard Deviation 11.96
|
-3.0 mg/L
Standard Deviation 19.60
|
-3.9 mg/L
Standard Deviation 19.47
|
-6.1 mg/L
Standard Deviation 27.02
|
-14.8 mg/L
Standard Deviation 26.38
|
-2.7 mg/L
Standard Deviation 13.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only participants with an assessment at Baseline and Week 16 and with an assessment at given time point.
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=33 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=36 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=35 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=34 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=31 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=33 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase
Week 8
|
16.6 units on a scale
Standard Deviation 25.38
|
18.9 units on a scale
Standard Deviation 40.35
|
34.6 units on a scale
Standard Deviation 36.22
|
24.9 units on a scale
Standard Deviation 30.95
|
39.7 units on a scale
Standard Deviation 40.76
|
23.3 units on a scale
Standard Deviation 30.34
|
—
|
—
|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Over Time During the Induction Phase
Week 16
|
14.5 units on a scale
Standard Deviation 29.15
|
24.6 units on a scale
Standard Deviation 42.98
|
41.8 units on a scale
Standard Deviation 47.02
|
32.1 units on a scale
Standard Deviation 38.57
|
44.4 units on a scale
Standard Deviation 40.05
|
22.5 units on a scale
Standard Deviation 27.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Only mITT participants with isolated ileal Crohn's disease at Baseline are included. Non-responder imputation.
Remission is defined as endoscopic remission AND clinical remission. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=9 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=10 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=6 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=5 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=6 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=10 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Isolated Ileal Crohn's Disease at Baseline Who Achieve Remission at Week 16
|
0.0 percentage of participants
|
20.0 percentage of participants
|
16.7 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission and a score above 450 indicates very severe disease.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Decrease in CDAI ≥ 100 Points From Baseline at Week 16
|
27.0 percentage of participants
|
33.3 percentage of participants
|
40.5 percentage of participants
|
44.4 percentage of participants
|
55.6 percentage of participants
|
31.4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16. (At Baseline, participants were allocated by randomization 1:1 to have their end of induction colonoscopy done at either Week 12 or Week 16; this endpoint combines the two time points.)Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Non-responder imputation.
Endoscopic remission: SES-CD ≤ 4 and at least two point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve > 50% Reduction From Baseline in SES-CD or Endoscopic Remission at Week 12/16
|
2.7 percentage of participants
|
12.8 percentage of participants
|
18.9 percentage of participants
|
25.0 percentage of participants
|
36.1 percentage of participants
|
25.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an average daily stool frequency ≥ 4.0 or average daily abdominal pain ≥ 2.0 at Baseline. Non-responder imputation.
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=33 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=38 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=33 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=34 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=30 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=32 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Modified Clinical Remission at Week 16 Among Participants With an Average Daily Stool Frequency ≥ 4.0 or Average Daily Abdominal Pain ≥ 2.0 at Baseline
|
12.1 percentage of participants
|
15.8 percentage of participants
|
30.3 percentage of participants
|
26.5 percentage of participants
|
36.7 percentage of participants
|
18.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an assessment at baseline and given time point. Non-responder imputation.
Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=30 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=35 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=34 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=27 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=29 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=30 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Abdominal Pain Rating Scale at Week 12
|
-1.1 units on a scale
Standard Deviation 1.84
|
-1.0 units on a scale
Standard Deviation 2.61
|
-2.6 units on a scale
Standard Deviation 2.53
|
-2.4 units on a scale
Standard Deviation 3.17
|
-2.7 units on a scale
Standard Deviation 2.52
|
-1.0 units on a scale
Standard Deviation 1.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT Population: all randomized participants who took at least 1 dose of study drug in the Induction Period. Includes only mITT participants with an assessment at Baseline and given time point. Non-responder imputation.
Abdominal pain was assessed on an abdominal pain rating scale, where subjects rated their average abdominal pain over the last 24 hours on a scale of 0 (none) to 10 (worst pain imaginable).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=28 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=34 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=33 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=26 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=28 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=28 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Abdominal Pain Rating Scale at Week 16
|
-0.9 units on a scale
Standard Deviation 2.27
|
-1.7 units on a scale
Standard Deviation 3.02
|
-2.8 units on a scale
Standard Deviation 2.77
|
-1.7 units on a scale
Standard Deviation 2.86
|
-2.3 units on a scale
Standard Deviation 2.42
|
-1.4 units on a scale
Standard Deviation 2.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non responder imputation.
Remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record. See definitions of responder and clinical responder in Outcome Measure 7 of this record.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Remission at Week 52
Responders
|
20.0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Remission at Week 52
Non-Responders
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.9 percentage of participants
|
13.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Remission at Week 52
Clinical Responders
|
12.5 percentage of participants
|
7.1 percentage of participants
|
13.8 percentage of participants
|
15.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Remission at Week 52
Clinical Non-Responders
|
0.0 percentage of participants
|
0.0 percentage of participants
|
4.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non responder imputation.
Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Responders
|
25.0 percentage of participants
|
25.0 percentage of participants
|
37.5 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Non-Responders
|
3.1 percentage of participants
|
10.0 percentage of participants
|
8.8 percentage of participants
|
17.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Clinical Responders
|
15.6 percentage of participants
|
21.4 percentage of participants
|
24.1 percentage of participants
|
26.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Remission at Week 52
Clinical Non-Responders
|
5.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Participants with daily stool frequency \>= 4.0 or daily abdominal pain \>= 2.0 at Induction Baseline. Non responder imputation
Endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus induction baseline and no subscore \> 1 in any individual variable. Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than induction baseline AND average daily abdominal pain \<= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=45 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=17 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=48 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=30 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=8 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=8 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders
|
29.4 percentage of participants
|
12.5 percentage of participants
|
33.3 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders
|
0 percentage of participants
|
0 percentage of participants
|
6.1 percentage of participants
|
15.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders
|
17.9 percentage of participants
|
7.1 percentage of participants
|
22.2 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Both Endoscopic Remission and Modified Clinical Remission at Week 52 Among Subjects With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders
|
0 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non responder imputation. Participants with an assessment at given time point.
Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Responders, Week 20
|
45.0 percentage of participants
|
37.5 percentage of participants
|
50.0 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Responders, Week 28
|
45.0 percentage of participants
|
37.5 percentage of participants
|
56.3 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Responders, Week 36
|
40.0 percentage of participants
|
37.5 percentage of participants
|
62.5 percentage of participants
|
30.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Responders, Week 44
|
40.0 percentage of participants
|
12.5 percentage of participants
|
68.8 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Responders, Week 52
|
30.0 percentage of participants
|
37.5 percentage of participants
|
62.5 percentage of participants
|
30.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Non-responders, Week 20
|
12.5 percentage of participants
|
40.0 percentage of participants
|
8.8 percentage of participants
|
8.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Non-responders, Week 28
|
12.5 percentage of participants
|
40.0 percentage of participants
|
8.8 percentage of participants
|
13.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Non-responders, Week 36
|
9.4 percentage of participants
|
10.0 percentage of participants
|
2.9 percentage of participants
|
13.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Non-responders, Week 44
|
12.5 percentage of participants
|
20.0 percentage of participants
|
5.9 percentage of participants
|
8.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Non-responders, Week 52
|
9.4 percentage of participants
|
10.0 percentage of participants
|
8.8 percentage of participants
|
13.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 20
|
40.6 percentage of participants
|
50.0 percentage of participants
|
37.9 percentage of participants
|
31.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 28
|
37.5 percentage of participants
|
50.0 percentage of participants
|
41.4 percentage of participants
|
42.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 36
|
34.4 percentage of participants
|
28.6 percentage of participants
|
37.9 percentage of participants
|
31.9 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 44
|
34.4 percentage of participants
|
21.4 percentage of participants
|
44.8 percentage of participants
|
31.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 52
|
25.0 percentage of participants
|
28.6 percentage of participants
|
41.4 percentage of participants
|
31.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical non-responders, Week 20
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical non-responders, Week 28
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical non-responders, Week 36
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical non-responders, Week 44
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase in Participants Receiving Upadacitinib in Induction
Clinical non-responders, Week 52
|
5.0 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively, and in clinical remission at Week 16. Non responder imputation. Participants with an assessment at given time point.
Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=13 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=6 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=9 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=4 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 28
|
84.6 percentage of participants
|
83.3 percentage of participants
|
55.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 36
|
76.9 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
75.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Responders, Week 20
|
80.0 percentage of participants
|
66.7 percentage of participants
|
71.4 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Responders, Week 28
|
90.0 percentage of participants
|
66.7 percentage of participants
|
57.1 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Responders, Week 36
|
80.0 percentage of participants
|
100 percentage of participants
|
71.4 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Responders, Week 44
|
80.0 percentage of participants
|
33.3 percentage of participants
|
71.4 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Responders, Week 52
|
60.0 percentage of participants
|
66.7 percentage of participants
|
71.4 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Non-responders, Week 20
|
66.7 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Non-responders, Week 28
|
66.7 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Non-responders, Week 36
|
66.7 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Non-responders, Week 44
|
66.7 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Non-responders, Week 52
|
33.3 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 20
|
76.9 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 44
|
76.9 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
75.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Maintain Clinical Remission Over Time Among Participants in Clinical Remission at Week 16 in Participants Receiving Upadacitinib in Induction
Clinical responders, Week 52
|
53.8 percentage of participants
|
50.0 percentage of participants
|
55.6 percentage of participants
|
75.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively, and with daily stool frequency \>= 4.0 or daily abdominal pain \>= 2.0 at Induction Baseline. Non responder imputation. Participants with an assessment at given time point.
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=45 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=17 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=48 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=30 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=8 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=8 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 52
|
41.2 percentage of participants
|
62.5 percentage of participants
|
73.3 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 20
|
42.9 percentage of participants
|
64.3 percentage of participants
|
51.9 percentage of participants
|
44.4 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 20
|
47.1 percentage of participants
|
62.5 percentage of participants
|
66.7 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 28
|
70.6 percentage of participants
|
50.0 percentage of participants
|
66.7 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 36
|
58.8 percentage of participants
|
87.5 percentage of participants
|
73.3 percentage of participants
|
30.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 44
|
47.1 percentage of participants
|
37.5 percentage of participants
|
73.3 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 20
|
17.9 percentage of participants
|
44.4 percentage of participants
|
12.1 percentage of participants
|
10.0 percentage of participants
|
42.9 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 28
|
21.4 percentage of participants
|
44.4 percentage of participants
|
9.1 percentage of participants
|
15.0 percentage of participants
|
42.9 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 36
|
14.3 percentage of participants
|
11.1 percentage of participants
|
6.1 percentage of participants
|
15.0 percentage of participants
|
57.1 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 44
|
14.3 percentage of participants
|
22.2 percentage of participants
|
6.1 percentage of participants
|
10.0 percentage of participants
|
42.9 percentage of participants
|
20.0 percentage of participants
|
37.5 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 52
|
7.1 percentage of participants
|
11.1 percentage of participants
|
12.1 percentage of participants
|
15.0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
37.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 28
|
57.1 percentage of participants
|
57.1 percentage of participants
|
48.1 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 36
|
46.4 percentage of participants
|
57.1 percentage of participants
|
48.1 percentage of participants
|
33.3 percentage of participants
|
80.0 percentage of participants
|
100 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 44
|
39.3 percentage of participants
|
35.7 percentage of participants
|
48.1 percentage of participants
|
33.3 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 52
|
28.6 percentage of participants
|
42.9 percentage of participants
|
51.9 percentage of participants
|
38.9 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 20
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 28
|
11.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 36
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 44
|
5.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 52
|
5.9 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively, and with modified clinical remission at Week 16 and daily stool frequency \>= 4.0 or daily abdominal pain \>= 2.0 at Induction Baseline. Non responder imputation. Participants with an assessment at given time point.
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline and average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=15 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=10 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=12 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=5 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=2 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=1 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=1 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 20
|
66.7 percentage of participants
|
60.0 percentage of participants
|
90.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 28
|
91.7 percentage of participants
|
60.0 percentage of participants
|
90.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 36
|
66.7 percentage of participants
|
100 percentage of participants
|
90.0 percentage of participants
|
75.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 44
|
66.7 percentage of participants
|
40.0 percentage of participants
|
90.0 percentage of participants
|
75.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 52
|
58.3 percentage of participants
|
80.0 percentage of participants
|
90.0 percentage of participants
|
75.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 20
|
66.7 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 28
|
100 percentage of participants
|
60.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 36
|
66.7 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 44
|
66.7 percentage of participants
|
40.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 52
|
33.3 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 20
|
66.7 percentage of participants
|
70.0 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 28
|
93.3 percentage of participants
|
60.0 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 36
|
66.7 percentage of participants
|
60.0 percentage of participants
|
83.3 percentage of participants
|
80.0 percentage of participants
|
100 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 44
|
66.7 percentage of participants
|
40.0 percentage of participants
|
83.3 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Modified Clinical Remission Over Time During Extension Phase Among Participants In Modified Clinical Remission At Week 16 and Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 52
|
53.3 percentage of participants
|
50.0 percentage of participants
|
83.3 percentage of participants
|
80.0 percentage of participants
|
50.0 percentage of participants
|
—
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
Response at Week 52 was defined as both endoscopic response at Week 52 and clinical response at Week 52. Endoscopic response: SES-CD at least 25% reduction from Baseline. Clinical response: average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Response at Week 52
Responders
|
50.0 percentage of participants
|
62.5 percentage of participants
|
68.8 percentage of participants
|
40.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Response at Week 52
Non-responders
|
6.3 percentage of participants
|
10.0 percentage of participants
|
14.7 percentage of participants
|
13.0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Response at Week 52
Clinical responders
|
34.4 percentage of participants
|
42.9 percentage of participants
|
51.7 percentage of participants
|
36.8 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Response at Week 52
Clinical non-responders
|
5.0 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SES-CD ≤ 2 at Week 52
Responders
|
10.0 percentage of participants
|
12.5 percentage of participants
|
31.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With SES-CD ≤ 2 at Week 52
Non-responders
|
6.3 percentage of participants
|
0 percentage of participants
|
8.8 percentage of participants
|
8.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With SES-CD ≤ 2 at Week 52
Clinical responders
|
6.3 percentage of participants
|
7.1 percentage of participants
|
20.7 percentage of participants
|
10.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With SES-CD ≤ 2 at Week 52
Clinical non-responders
|
10.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SES-CD = 0 at Week 52
Responders
|
10.0 percentage of participants
|
12.5 percentage of participants
|
31.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With SES-CD = 0 at Week 52
Non-responders
|
3.1 percentage of participants
|
0 percentage of participants
|
8.8 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With SES-CD = 0 at Week 52
Clinical responders
|
6.3 percentage of participants
|
7.1 percentage of participants
|
20.7 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With SES-CD = 0 at Week 52
Clinical non-responders
|
5.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
Endoscopic response was defined as SES-CD at least 25% reduction from Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Responders
|
60.0 percentage of participants
|
75.0 percentage of participants
|
75.0 percentage of participants
|
40.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Non-responders
|
15.6 percentage of participants
|
20.0 percentage of participants
|
20.6 percentage of participants
|
17.4 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Clinical responders
|
40.6 percentage of participants
|
57.1 percentage of participants
|
55.2 percentage of participants
|
42.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Clinical non-responders
|
20.0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
Enhanced endoscopic response was defined as SES-CD reduction from Induction Baseline \> 50% (or for an Induction Baseline SES-CD of 4, at least a 2 point reduction from Induction Baseline). SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Responders
|
40.0 percentage of participants
|
50.0 percentage of participants
|
68.8 percentage of participants
|
30.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Non-responders
|
12.5 percentage of participants
|
0 percentage of participants
|
11.8 percentage of participants
|
17.4 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
11.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Clinical responders
|
28.1 percentage of participants
|
28.6 percentage of participants
|
44.8 percentage of participants
|
36.8 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Endoscopic Response at Week 52
Clinical non-responders
|
15.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
Endoscopic Improvement: SES-CD reduction from Induction Baseline \> 50% or endoscopic remission. Endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus Induction Baseline and no subscore \> 1 in any individual variable. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Responders
|
50.0 percentage of participants
|
50.0 percentage of participants
|
68.8 percentage of participants
|
30.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Non-responders
|
12.5 percentage of participants
|
10.0 percentage of participants
|
11.8 percentage of participants
|
17.4 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
11.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Clinical responders
|
34.4 percentage of participants
|
35.7 percentage of participants
|
44.8 percentage of participants
|
36.8 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Improvement at Week 52
Clinical non-responders
|
15.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
Endoscopic healing was defined as SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore \>= 1 at Induction Baseline. SES-CD subscores assess the following: presence and size of ulcers in 5 visualized bowel segments; extent of ulcerated surface in 5 visualized bowel segments; extent of affected surface in 5 visualized bowel segments; presence and type of narrowings in 5 visualized bowel segments. Subscores range from 0 to 15, and are summed for a total SES-CD score ranging from 0 to 56; higher scores indicate greater severity of mucosal inflammation.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Responders
|
15.0 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Non-responders
|
9.4 percentage of participants
|
10.0 percentage of participants
|
8.8 percentage of participants
|
8.7 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Clinical responders
|
9.4 percentage of participants
|
21.4 percentage of participants
|
31.0 percentage of participants
|
10.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Endoscopic Healing at Week 52
Clinical non-responders
|
15.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
Clinical response was defined as average daily stool frequency at least 30% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 30% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Responders, Week 20
|
85.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
80.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Responders, Week 28
|
85.0 percentage of participants
|
75.0 percentage of participants
|
81.3 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Responders, Week 36
|
75.0 percentage of participants
|
100 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Responders, Week 44
|
50.0 percentage of participants
|
87.5 percentage of participants
|
81.3 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Responders, Week 52
|
55.0 percentage of participants
|
87.5 percentage of participants
|
68.8 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-responders, Week 20
|
43.8 percentage of participants
|
60.0 percentage of participants
|
41.2 percentage of participants
|
39.1 percentage of participants
|
75.0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-responders, Week 28
|
40.6 percentage of participants
|
60.0 percentage of participants
|
29.4 percentage of participants
|
26.1 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-responders, Week 36
|
28.1 percentage of participants
|
40.0 percentage of participants
|
26.5 percentage of participants
|
17.4 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Clinical responders, Week 44
|
50.0 percentage of participants
|
71.4 percentage of participants
|
72.4 percentage of participants
|
42.1 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-responders, Week 44
|
25.0 percentage of participants
|
30.0 percentage of participants
|
26.5 percentage of participants
|
21.7 percentage of participants
|
37.5 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-responders, Week 52
|
21.9 percentage of participants
|
30.0 percentage of participants
|
26.5 percentage of participants
|
13.0 percentage of participants
|
37.5 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Clinical responders, Week 20
|
78.1 percentage of participants
|
100 percentage of participants
|
93.1 percentage of participants
|
78.9 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Clinical responders, Week 28
|
78.1 percentage of participants
|
78.6 percentage of participants
|
69.0 percentage of participants
|
57.9 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-clinical responders, Week 20
|
30.0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Clinical responders, Week 36
|
65.6 percentage of participants
|
78.6 percentage of participants
|
65.5 percentage of participants
|
47.4 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Clinical responders, Week 52
|
50.0 percentage of participants
|
71.4 percentage of participants
|
62.1 percentage of participants
|
42.1 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-clinical responders, Week 28
|
25.0 percentage of participants
|
25.0 percentage of participants
|
14.3 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-clinical responders, Week 36
|
15.0 percentage of participants
|
25.0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-clinical responders, Week 44
|
10.0 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Achieve Clinical Response Over Time During Extension Phase
Non-clinical responders, Week 52
|
10.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Includes intent-to-treat responder (ITT-R) and non-responder (ITT-NR) analysis sets: all re-randomized participants in the double-blind Extension Phase who were responders and nonresponders at Week 16 of the Induction Period, respectively. Non-responder imputation.
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline OR average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Non-responders, Week 36
|
28.1 percentage of participants
|
40.0 percentage of participants
|
26.5 percentage of participants
|
17.4 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Non-responders, Week 44
|
21.9 percentage of participants
|
30.0 percentage of participants
|
23.5 percentage of participants
|
21.7 percentage of participants
|
37.5 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Non-responders, Week 52
|
21.9 percentage of participants
|
30.0 percentage of participants
|
26.5 percentage of participants
|
13.0 percentage of participants
|
37.5 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical responders, Week 20
|
62.5 percentage of participants
|
85.7 percentage of participants
|
93.1 percentage of participants
|
63.2 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical responders, Week 28
|
71.9 percentage of participants
|
78.6 percentage of participants
|
69.0 percentage of participants
|
57.9 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Responders, Week 20
|
70.0 percentage of participants
|
87.5 percentage of participants
|
100 percentage of participants
|
70.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Responders, Week 28
|
80.0 percentage of participants
|
75.0 percentage of participants
|
81.3 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Responders, Week 36
|
75.0 percentage of participants
|
100 percentage of participants
|
75.0 percentage of participants
|
40.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Responders, Week 44
|
50.0 percentage of participants
|
62.5 percentage of participants
|
75.0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Responders, Week 52
|
50.0 percentage of participants
|
87.5 percentage of participants
|
68.8 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Non-responders, Week 20
|
34.4 percentage of participants
|
50.0 percentage of participants
|
38.2 percentage of participants
|
26.1 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Non-responders, Week 28
|
37.5 percentage of participants
|
60.0 percentage of participants
|
29.4 percentage of participants
|
21.7 percentage of participants
|
70.0 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical responders, Week 36
|
65.6 percentage of participants
|
78.6 percentage of participants
|
65.5 percentage of participants
|
42.1 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical responders, Week 44
|
50.0 percentage of participants
|
57.1 percentage of participants
|
65.5 percentage of participants
|
42.1 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical responders, Week 52
|
46.9 percentage of participants
|
71.4 percentage of participants
|
62.1 percentage of participants
|
42.1 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical non-responders, Week 20
|
25.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical non-responders, Week 28
|
25.0 percentage of participants
|
25.0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical non-responders, Week 36
|
15.0 percentage of participants
|
25.0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical non-responders, Week 44
|
5.0 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase
Clinical non-responders, Week 52
|
10.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Subjects from ITT population with enhanced clinical response at Week 16. Non responder imputation.
Enhanced clinical response was defined as average daily stool frequency at least 60% reduction from Induction Baseline and average daily abdominal pain not worse than Induction Baseline or average daily abdominal pain at least 35% reduction from Induction Baseline and average daily stool frequency not worse than Induction Baseline or modified clinical remission (average daily stool frequency ≤ 2.8 and not worse than Induction baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction baseline). The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=30 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=13 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=28 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=16 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=4 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=1 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=2 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=1 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Responders, Week 44
|
50.0 percentage of participants
|
71.4 percentage of participants
|
75.0 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Responders, Week 20
|
63.3 percentage of participants
|
92.3 percentage of participants
|
92.9 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Responders, Week 52
|
46.7 percentage of participants
|
69.2 percentage of participants
|
64.3 percentage of participants
|
46.7 percentage of participants
|
75.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Responders, Week 52
|
50.0 percentage of participants
|
85.7 percentage of participants
|
68.8 percentage of participants
|
44.4 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Non-responders, Week 20
|
50.0 percentage of participants
|
83.3 percentage of participants
|
83.3 percentage of participants
|
57.1 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Non-responders, Week 28
|
70.0 percentage of participants
|
83.3 percentage of participants
|
58.3 percentage of participants
|
57.1 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Responders, Week 20
|
70.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Responders, Week 28
|
80.0 percentage of participants
|
71.4 percentage of participants
|
81.3 percentage of participants
|
55.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Responders, Week 36
|
75.0 percentage of participants
|
100 percentage of participants
|
75.0 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Non-responders, Week 36
|
50.0 percentage of participants
|
50.0 percentage of participants
|
58.3 percentage of participants
|
57.1 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Non-responders, Week 44
|
50.0 percentage of participants
|
50.0 percentage of participants
|
58.3 percentage of participants
|
57.1 percentage of participants
|
75.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Non-responders, Week 52
|
40.0 percentage of participants
|
50.0 percentage of participants
|
58.3 percentage of participants
|
42.9 percentage of participants
|
75.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Responders, Week 28
|
76.7 percentage of participants
|
76.9 percentage of participants
|
71.4 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Responders, Week 36
|
66.7 percentage of participants
|
76.9 percentage of participants
|
67.9 percentage of participants
|
46.7 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Responders, Week 44
|
50.0 percentage of participants
|
61.5 percentage of participants
|
67.9 percentage of participants
|
46.7 percentage of participants
|
75.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Non-responders, Week 20
|
—
|
—
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Non-responders, Week 28
|
—
|
—
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Non-responders, Week 36
|
—
|
—
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Non-responders, Week 44
|
—
|
—
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Enhanced Clinical Response Over Time During Extension Phase Among Participants In Enhanced Clinical Response At Week 16
Clinical Non-responders, Week 52
|
—
|
—
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Participants from ITT population with man average daily stool frequency \>= 2.5 and average daily abdominal pain \>= 2.0 at Induction Baseline. Participants Receiving Upadacitinib in Induction. Non responder imputation.
Clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=23 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=11 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=23 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=14 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 20
|
44.4 percentage of participants
|
16.7 percentage of participants
|
37.5 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 28
|
55.6 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 36
|
44.4 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 44
|
44.4 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders, Week 52
|
33.3 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 20
|
21.4 percentage of participants
|
40.0 percentage of participants
|
6.7 percentage of participants
|
11.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 28
|
21.4 percentage of participants
|
40.0 percentage of participants
|
6.7 percentage of participants
|
22.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 36
|
21.4 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
22.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 44
|
14.3 percentage of participants
|
20.0 percentage of participants
|
6.7 percentage of participants
|
11.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders, Week 52
|
7.1 percentage of participants
|
20.0 percentage of participants
|
13.3 percentage of participants
|
22.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 20
|
41.2 percentage of participants
|
30.0 percentage of participants
|
26.7 percentage of participants
|
22.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 28
|
47.1 percentage of participants
|
30.0 percentage of participants
|
33.3 percentage of participants
|
44.4 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 36
|
41.2 percentage of participants
|
20.0 percentage of participants
|
26.7 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 44
|
35.3 percentage of participants
|
10.0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders, Week 52
|
23.5 percentage of participants
|
30.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 20
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 28
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 36
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 44
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Clinical Remission Over Time During Extension Phase Among Participants With an Average Daily Stool Frequency ≥ 2.5 and Average Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders, Week 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=23 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=7 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=20 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=14 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=5 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Responders, Week 36
|
50.0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Responders, Week 44
|
37.5 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Responders, Week 52
|
50.0 percentage of participants
|
100 percentage of participants
|
62.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Non-responders, Week 20
|
13.3 percentage of participants
|
40.0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Non-responders, Week 28
|
6.7 percentage of participants
|
40.0 percentage of participants
|
16.7 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Non-responders, Week 36
|
13.3 percentage of participants
|
40.0 percentage of participants
|
8.3 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Non-responders, Week 44
|
26.7 percentage of participants
|
40.0 percentage of participants
|
25.0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Non-responders, Week 52
|
20.0 percentage of participants
|
40.0 percentage of participants
|
25.0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical responders, Week 20
|
40.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical responders, Week 28
|
33.3 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical responders, Week 36
|
40.0 percentage of participants
|
66.7 percentage of participants
|
35.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical responders, Week 44
|
40.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical responders, Week 52
|
46.7 percentage of participants
|
66.7 percentage of participants
|
57.1 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical non-responders, Week 20
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical non-responders, Week 28
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical non-responders, Week 36
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical non-responders, Week 44
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Clinical non-responders, Week 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Responders, Week 20
|
50.0 percentage of participants
|
50.0 percentage of participants
|
75.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve CDAI < 150 Over Time
Responders, Week 28
|
50.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
Steroid-free remission at Week 52 was defined as both endoscopic remission at Week 52 and clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2 point reduction versus Induction Baseline and no subscore \> 1 in any individual variable. Clinical remission: Average daily stool frequency ≤ 1.5 and not worse than baseline AND average daily abdominal pain ≤ 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). See SES-CD description details in the first primary endpoint description of this record.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=23 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=7 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=20 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=14 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=5 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52
Responders
|
25.0 percentage of participants
|
0 percentage of participants
|
37.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52
Non-responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52
Clinical Responders
|
13.3 percentage of participants
|
0 percentage of participants
|
21.4 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Remission At Week 52
Clinical non-responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
Steroid-free clinical remission was defined as average daily stool frequency \<= 1.5 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=23 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=7 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=20 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=14 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=5 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical responders, Week 20
|
40.0 percentage of participants
|
50.0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Responders, Week 20
|
50.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Responders, Week 28
|
37.5 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Responders, Week 36
|
37.5 percentage of participants
|
100 percentage of participants
|
62.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Responders, Week 44
|
37.5 percentage of participants
|
0 percentage of participants
|
62.5 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Responders, Week 52
|
25.0 percentage of participants
|
100 percentage of participants
|
62.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Non-responders, Week 20
|
13.3 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Non-responders, Week 28
|
6.7 percentage of participants
|
40.0 percentage of participants
|
16.7 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Non-responders, Week 36
|
6.7 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Non-responders, Week 44
|
20.0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Non-responders, Week 52
|
13.3 percentage of participants
|
20.0 percentage of participants
|
8.3 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical responders, Week 28
|
26.7 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical responders, Week 36
|
26.7 percentage of participants
|
50.0 percentage of participants
|
35.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical responders, Week 44
|
40.0 percentage of participants
|
33.3 percentage of participants
|
35.7 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical responders, Week 52
|
26.7 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical non-responders, Week 20
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical non-responders, Week 28
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical non-responders, Week 36
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical non-responders, Week 44
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Clinical Remission Over Time
Clinical non-responders, Week 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Participants from ITT population taking corticosteroids at Induction Baseline and Daily Stool Frequency \>= 4.0 OR Daily Abdominal Pain \>= 2.0 at Induction Baseline. Non responder imputation.
Steroid-free modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than Induction Baseline AND average daily abdominal pain \<= 1.0 and not worse than Induction Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=18 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=7 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=20 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=13 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=4 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Responders, Week 44
|
33.3 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Responders, Week 52
|
33.3 percentage of participants
|
100 percentage of participants
|
62.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Non-responders, Week 20
|
8.3 percentage of participants
|
40.0 percentage of participants
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Non-responders, Week 28
|
16.7 percentage of participants
|
40.0 percentage of participants
|
16.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Non-responders, Week 36
|
8.3 percentage of participants
|
20.0 percentage of participants
|
8.3 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Non-responders, Week 44
|
16.7 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Non-responders, Week 52
|
8.3 percentage of participants
|
20.0 percentage of participants
|
16.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical responders, Week 20
|
25.0 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Responders, Week 20
|
33.3 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Responders, Week 28
|
50.0 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Responders, Week 36
|
50.0 percentage of participants
|
100 percentage of participants
|
62.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical responders, Week 28
|
41.7 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical responders, Week 36
|
33.3 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical responders, Week 44
|
33.3 percentage of participants
|
50.0 percentage of participants
|
35.7 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical responders, Week 52
|
25.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical non-responders, Week 20
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical non-responders, Week 28
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical non-responders, Week 36
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical non-responders, Week 44
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline and With Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Modified Clinical Remission Over Time
Clinical non-responders, Week 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from ITT population taking corticosteroids at Induction Baseline. Non responder imputation.
Steroid-free endoscopic remission was defined as SES-CD \<= 4 and at least 2 points reduction versus Induction Baseline and no subscore \> 1 in any individual variable. Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=23 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=7 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=20 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=14 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=5 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52
Responders
|
25.0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52
Non-responders
|
0 percentage of participants
|
20.0 percentage of participants
|
8.3 percentage of participants
|
11.1 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52
Clinical responders
|
13.3 percentage of participants
|
16.7 percentage of participants
|
35.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
|
Percentage of Participants Taking Corticosteroids at Induction Baseline Who Discontinued Corticosteroid Use and Achieve Endoscopic Remission at Week 52
Clinical non-responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Non responder imputation.
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A score below 150 indicates remission.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical responders, Week 36
|
59.4 percentage of participants
|
64.3 percentage of participants
|
44.8 percentage of participants
|
31.6 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical responders, Week 52
|
43.8 percentage of participants
|
50.0 percentage of participants
|
55.2 percentage of participants
|
36.8 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical non- responders, Week 36
|
0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical non- responders, Week 44
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Responders, Week 20
|
65.0 percentage of participants
|
50.0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Responders, Week 28
|
75.0 percentage of participants
|
25.0 percentage of participants
|
62.5 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Responders, Week 36
|
70.0 percentage of participants
|
75.0 percentage of participants
|
62.5 percentage of participants
|
30.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Responders, Week 44
|
45.0 percentage of participants
|
37.5 percentage of participants
|
62.5 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Responders, Week 52
|
55.0 percentage of participants
|
50.0 percentage of participants
|
68.8 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Non-responders, Week 20
|
28.1 percentage of participants
|
50.0 percentage of participants
|
17.6 percentage of participants
|
8.7 percentage of participants
|
75.0 percentage of participants
|
20.0 percentage of participants
|
11.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Non-responders, Week 28
|
15.6 percentage of participants
|
40.0 percentage of participants
|
17.6 percentage of participants
|
13.0 percentage of participants
|
37.5 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Non-responders, Week 36
|
15.6 percentage of participants
|
30.0 percentage of participants
|
14.7 percentage of participants
|
13.0 percentage of participants
|
37.5 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Non-responders, Week 44
|
18.8 percentage of participants
|
30.0 percentage of participants
|
17.6 percentage of participants
|
8.7 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Non-responders, Week 52
|
9.4 percentage of participants
|
30.0 percentage of participants
|
20.6 percentage of participants
|
13.0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical responders, Week 20
|
59.4 percentage of participants
|
64.3 percentage of participants
|
51.7 percentage of participants
|
36.8 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical responders, Week 28
|
56.3 percentage of participants
|
42.9 percentage of participants
|
48.3 percentage of participants
|
47.4 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical responders, Week 44
|
40.6 percentage of participants
|
42.9 percentage of participants
|
55.2 percentage of participants
|
31.6 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical non- responders, Week 20
|
15.0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical non- responders, Week 28
|
10.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage Of Participants Who Achieve CDAI < 150 Over Time During Extension Phase
Clinical non- responders, Week 52
|
0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, Week 28, Week 36, Week 44, Week 52Population: Non responder imputation.
CDAI is used to quantify the signs and symptoms of subjects with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. A 70-point decrease in the CDAI index refers to improvement in the disease activity from Baseline.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=52 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=50 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=33 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=5 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=9 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Responders, Week 20
|
80.0 percentage of participants
|
100 percentage of participants
|
93.8 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Responders, Week 36
|
75.0 percentage of participants
|
100 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Responders, Week 44
|
60.0 percentage of participants
|
87.5 percentage of participants
|
81.3 percentage of participants
|
40.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical responders, Week 20
|
75.0 percentage of participants
|
100 percentage of participants
|
89.7 percentage of participants
|
63.2 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical responders, Week 28
|
75.0 percentage of participants
|
71.4 percentage of participants
|
58.6 percentage of participants
|
57.9 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Responders, Week 28
|
85.0 percentage of participants
|
62.5 percentage of participants
|
68.8 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Responders, Week 52
|
55.0 percentage of participants
|
75.0 percentage of participants
|
75.0 percentage of participants
|
40.0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Non-responders, Week 20
|
46.9 percentage of participants
|
70.0 percentage of participants
|
47.1 percentage of participants
|
34.8 percentage of participants
|
75.0 percentage of participants
|
20.0 percentage of participants
|
22.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Non-responders, Week 28
|
34.4 percentage of participants
|
60.0 percentage of participants
|
29.4 percentage of participants
|
30.4 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Non-responders, Week 36
|
28.1 percentage of participants
|
50.0 percentage of participants
|
26.5 percentage of participants
|
17.4 percentage of participants
|
50.0 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Non-responders, Week 44
|
25.0 percentage of participants
|
30.0 percentage of participants
|
29.4 percentage of participants
|
26.1 percentage of participants
|
37.5 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Non-responders, Week 52
|
12.5 percentage of participants
|
40.0 percentage of participants
|
26.5 percentage of participants
|
17.4 percentage of participants
|
37.5 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical responders, Week 36
|
65.6 percentage of participants
|
85.7 percentage of participants
|
62.1 percentage of participants
|
42.1 percentage of participants
|
83.3 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical responders, Week 44
|
56.3 percentage of participants
|
71.4 percentage of participants
|
72.4 percentage of participants
|
42.1 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical responders, Week 52
|
46.9 percentage of participants
|
71.4 percentage of participants
|
62.1 percentage of participants
|
36.8 percentage of participants
|
66.7 percentage of participants
|
100 percentage of participants
|
25.0 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical non-responders, Week 20
|
35.0 percentage of participants
|
25.0 percentage of participants
|
23.8 percentage of participants
|
14.3 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical non-responders, Week 28
|
20.0 percentage of participants
|
25.0 percentage of participants
|
19.0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical non-responders, Week 36
|
15.0 percentage of participants
|
25.0 percentage of participants
|
14.3 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical non-responders, Week 44
|
10.0 percentage of participants
|
0 percentage of participants
|
9.5 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Decrease in CDAI ≥ 70 Points From Induction Baseline Over Time During Extension Phase
Clinical non-responders, Week 52
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28, Week 52Population: Participants from ITT population with an assessment at given time point. Last observation carried forward.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=39 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=15 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=30 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=13 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=5 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=4 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=2 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Responders, Week 28
|
-153.4 mcg/g
Standard Deviation 2722.96
|
-532.0 mcg/g
Standard Deviation 519.42
|
-2878.6 mcg/g
Standard Deviation 2584.43
|
-3563.7 mcg/g
Standard Deviation 4747.26
|
-194.0 mcg/g
Standard Deviation NA
not applicable (1 participant in arm)
|
—
|
—
|
—
|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Responders, Week 52
|
-51.9 mcg/g
Standard Deviation 2650.98
|
-524.1 mcg/g
Standard Deviation 521.31
|
-3047.5 mcg/g
Standard Deviation 2509.27
|
-2371.8 mcg/g
Standard Deviation 2786.97
|
-44.0 mcg/g
Standard Deviation NA
not applicable (1 participant in arm)
|
—
|
—
|
—
|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Non-responders, Week 28
|
-150.3 mcg/g
Standard Deviation 958.76
|
-148.3 mcg/g
Standard Deviation 1315.46
|
-834.5 mcg/g
Standard Deviation 3011.51
|
-850.2 mcg/g
Standard Deviation 1821.34
|
-16.5 mcg/g
Standard Deviation 304.33
|
-121.0 mcg/g
Standard Deviation 395.16
|
-326.8 mcg/g
Standard Deviation 817.71
|
760.5 mcg/g
Standard Deviation 1075.51
|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Non-responders, Week 52
|
-87.2 mcg/g
Standard Deviation 1494.35
|
88.3 mcg/g
Standard Deviation 1689.67
|
-704.0 mcg/g
Standard Deviation 2801.08
|
-562.8 mcg/g
Standard Deviation 1738.58
|
-8.3 mcg/g
Standard Deviation 344.29
|
-121.0 mcg/g
Standard Deviation 395.16
|
-434.0 mcg/g
Standard Deviation 1030.64
|
760.5 mcg/g
Standard Deviation 1075.51
|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Clinical responders, Week 28
|
-226.2 mcg/g
Standard Deviation 2261.16
|
-424.5 mcg/g
Standard Deviation 1102.22
|
-2794.6 mcg/g
Standard Deviation 3018.26
|
-2099.3 mcg/g
Standard Deviation 3083.34
|
-65.0 mcg/g
Standard Deviation 316.06
|
-694.0 mcg/g
Standard Deviation NA
not applicable (1 participant in arm)
|
117.5 mcg/g
Standard Deviation 166.17
|
—
|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Clinical responders, Week 52
|
1.0 mcg/g
Standard Deviation 2457.22
|
-239.3 mcg/g
Standard Deviation 1443.14
|
-2617.4 mcg/g
Standard Deviation 3232.04
|
-1510.3 mcg/g
Standard Deviation 2773.90
|
-44.3 mcg/g
Standard Deviation 350.61
|
-694.0 mcg/g
Standard Deviation NA
not applicable (1 participant in arm)
|
117.5 mcg/g
Standard Deviation 166.17
|
—
|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Clinical non-responders, Week 28
|
3.7 mcg/g
Standard Deviation 766.69
|
-30.7 mcg/g
Standard Deviation 32.65
|
606.0 mcg/g
Standard Deviation 1133.70
|
183.7 mcg/g
Standard Deviation 443.97
|
0.0 mcg/g
Standard Deviation NA
not applicable (1 participant in arm)
|
70.0 mcg/g
Standard Deviation 123.85
|
-771.0 mcg/g
Standard Deviation 1090.36
|
760.5 mcg/g
Standard Deviation 1075.51
|
|
Change From Induction Baseline in Fecal Calprotectin Level Over Time During Extension Phase
Clinical non-responders, Week 52
|
-220.2 mcg/g
Standard Deviation 514.97
|
-30.7 mcg/g
Standard Deviation 32.65
|
213.3 mcg/g
Standard Deviation 802.34
|
183.7 mcg/g
Standard Deviation 443.97
|
0.0 mcg/g
Standard Deviation NA
not applicable (1 participant in arm)
|
70.0 mcg/g
Standard Deviation 123.85
|
-985.5 mcg/g
Standard Deviation 1393.71
|
760.5 mcg/g
Standard Deviation 1075.51
|
SECONDARY outcome
Timeframe: Baseline, Week 20, Week 28, Week 36, Week 44, Week 52Population: Participants from ITT population with an assessment at given time point. Last observation carried forward.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=49 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=18 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=47 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=31 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=9 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=4 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=7 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=4 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical non-responders, Week 36
|
-1.7 mg/L
Standard Deviation 8.94
|
0.4 mg/L
Standard Deviation 0.51
|
-3.4 mg/L
Standard Deviation 8.04
|
-6.1 mg/L
Standard Deviation 13.28
|
7.3 mg/L
Standard Deviation 12.63
|
0.6 mg/L
Standard Deviation 0.50
|
-4.1 mg/L
Standard Deviation 7.77
|
12.7 mg/L
Standard Deviation 11.20
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Responders, Week 20
|
-9.5 mg/L
Standard Deviation 21.77
|
-9.4 mg/L
Standard Deviation 11.14
|
-20.8 mg/L
Standard Deviation 19.78
|
4.1 mg/L
Standard Deviation 36.50
|
-3.1 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Responders, Week 28
|
-6.0 mg/L
Standard Deviation 22.53
|
-3.6 mg/L
Standard Deviation 16.12
|
-21.8 mg/L
Standard Deviation 17.93
|
7.0 mg/L
Standard Deviation 35.65
|
-4.2 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Responders, Week 36
|
-1.8 mg/L
Standard Deviation 25.57
|
-7.2 mg/L
Standard Deviation 10.86
|
-22.5 mg/L
Standard Deviation 18.01
|
5.6 mg/L
Standard Deviation 35.87
|
-4.0 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Responders, Week 44
|
-5.4 mg/L
Standard Deviation 22.95
|
-8.5 mg/L
Standard Deviation 12.18
|
-21.5 mg/L
Standard Deviation 19.78
|
5.8 mg/L
Standard Deviation 35.77
|
10.6 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Responders, Week 52
|
-4.3 mg/L
Standard Deviation 22.68
|
-7.0 mg/L
Standard Deviation 12.66
|
-20.4 mg/L
Standard Deviation 18.76
|
6.2 mg/L
Standard Deviation 35.82
|
0.4 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Non-responders, Week 20
|
-2.2 mg/L
Standard Deviation 9.72
|
-1.6 mg/L
Standard Deviation 8.24
|
-8.5 mg/L
Standard Deviation 25.00
|
-8.0 mg/L
Standard Deviation 18.77
|
0.3 mg/L
Standard Deviation 10.89
|
-1.0 mg/L
Standard Deviation 0.97
|
-6.8 mg/L
Standard Deviation 8.82
|
-1.5 mg/L
Standard Deviation 2.39
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Non-responders, Week 28
|
-3.0 mg/L
Standard Deviation 9.61
|
-0.2 mg/L
Standard Deviation 5.92
|
-6.4 mg/L
Standard Deviation 27.03
|
-6.5 mg/L
Standard Deviation 20.14
|
0.3 mg/L
Standard Deviation 9.78
|
-1.1 mg/L
Standard Deviation 1.06
|
-5.9 mg/L
Standard Deviation 6.58
|
3.8 mg/L
Standard Deviation 9.55
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Non-responders, Week 36
|
-0.7 mg/L
Standard Deviation 8.86
|
5.2 mg/L
Standard Deviation 15.34
|
-7.3 mg/L
Standard Deviation 24.87
|
0.8 mg/L
Standard Deviation 45.98
|
3.3 mg/L
Standard Deviation 8.88
|
0.5 mg/L
Standard Deviation 0.41
|
-3.7 mg/L
Standard Deviation 7.80
|
8.3 mg/L
Standard Deviation 12.71
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Non-responders, Week 44
|
-1.3 mg/L
Standard Deviation 7.82
|
11.1 mg/L
Standard Deviation 33.68
|
-4.1 mg/L
Standard Deviation 27.93
|
0.9 mg/L
Standard Deviation 45.88
|
3.0 mg/L
Standard Deviation 9.51
|
-0.9 mg/L
Standard Deviation 0.87
|
-4.1 mg/L
Standard Deviation 7.12
|
5.5 mg/L
Standard Deviation 9.39
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Non-responders, Week 52
|
-1.2 mg/L
Standard Deviation 8.67
|
2.8 mg/L
Standard Deviation 17.81
|
-3.4 mg/L
Standard Deviation 32.58
|
1.3 mg/L
Standard Deviation 45.26
|
4.7 mg/L
Standard Deviation 11.50
|
-0.2 mg/L
Standard Deviation 0.42
|
-5.1 mg/L
Standard Deviation 8.52
|
2.5 mg/L
Standard Deviation 9.89
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical responders, Week 20
|
-7.1 mg/L
Standard Deviation 18.6
|
-6.9 mg/L
Standard Deviation 10.80
|
-18.0 mg/L
Standard Deviation 29.20
|
-3.0 mg/L
Standard Deviation 31.35
|
-3.8 mg/L
Standard Deviation 5.59
|
-2.2 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
-9.5 mg/L
Standard Deviation 12.15
|
-4.4 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical responders, Week 28
|
-5.4 mg/L
Standard Deviation 19.26
|
-2.0 mg/L
Standard Deviation 12.93
|
-19.2 mg/L
Standard Deviation 30.13
|
0.0 mg/L
Standard Deviation 32.17
|
-4.0 mg/L
Standard Deviation 4.77
|
-2.3 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
-6.1 mg/L
Standard Deviation 6.32
|
-5.3 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical responders, Week 36
|
-0.8 mg/L
Standard Deviation 20.85
|
-0.5 mg/L
Standard Deviation 16.69
|
-18.6 mg/L
Standard Deviation 28.62
|
9.1 mg/L
Standard Deviation 56.33
|
0.1 mg/L
Standard Deviation 5.93
|
0.4 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
-3.2 mg/L
Standard Deviation 9.54
|
-4.9 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical responders, Week 44
|
-3.5 mg/L
Standard Deviation 18.87
|
3.0 mg/L
Standard Deviation 31.54
|
-15.3 mg/L
Standard Deviation 32.75
|
9.3 mg/L
Standard Deviation 56.18
|
2.2 mg/L
Standard Deviation 7.92
|
-1.5 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
-1.8 mg/L
Standard Deviation 7.26
|
-3.9 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical responders, Week 52
|
-2.8 mg/L
Standard Deviation 18.91
|
-2.1 mg/L
Standard Deviation 18.36
|
-13.9 mg/L
Standard Deviation 37.06
|
10.2 mg/L
Standard Deviation 55.66
|
2.7 mg/L
Standard Deviation 10.77
|
-0.7 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
-4.2 mg/L
Standard Deviation 11.29
|
-4.6 mg/L
Standard Deviation NA
not applicable (1 participants analyzed)
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical non-responders, Week 20
|
-1.7 mg/L
Standard Deviation 10.51
|
1.4 mg/L
Standard Deviation 2.83
|
-4.9 mg/L
Standard Deviation 8.36
|
-6.2 mg/L
Standard Deviation 15.35
|
10.9 mg/L
Standard Deviation 15.47
|
-0.6 mg/L
Standard Deviation 0.71
|
-4.8 mg/L
Standard Deviation 6.69
|
-0.5 mg/L
Standard Deviation 1.68
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical non-responders, Week 28
|
-2.2 mg/L
Standard Deviation 7.71
|
-0.6 mg/L
Standard Deviation 1.43
|
-0.6 mg/L
Standard Deviation 6.82
|
-5.7 mg/L
Standard Deviation 15.26
|
7.3 mg/L
Standard Deviation 12.63
|
-0.7 mg/L
Standard Deviation 0.81
|
-5.8 mg/L
Standard Deviation 7.73
|
6.8 mg/L
Standard Deviation 9.10
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical non-responders, Week 44
|
-1.9 mg/L
Standard Deviation 7.83
|
0.4 mg/L
Standard Deviation 0.51
|
-2.3 mg/L
Standard Deviation 9.37
|
-6.2 mg/L
Standard Deviation 13.15
|
7.3 mg/L
Standard Deviation 12.63
|
-0.7 mg/L
Standard Deviation 0.95
|
-5.8 mg/L
Standard Deviation 7.55
|
8.6 mg/L
Standard Deviation 8.55
|
|
Change From Induction Baseline in Hs-CRP Over Time During Extension Phase
Clinical non-responders, Week 52
|
-1.9 mg/L
Standard Deviation 8.11
|
0.4 mg/L
Standard Deviation 0.51
|
-2.2 mg/L
Standard Deviation 9.28
|
-6.3 mg/L
Standard Deviation 11.71
|
7.3 mg/L
Standard Deviation 12.63
|
0.0 mg/L
Standard Deviation 0.33
|
-5.8 mg/L
Standard Deviation 7.66
|
4.9 mg/L
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from ITT population with an assessment at given time point.
The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The total score ranges from 32 to 224 using the 7-point response options, with higher scores indicating better health-related quality of life. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function, and social function. Each subscale can be computed with total scores ranging from 10 to 70, 5 to 35, 12 to 84, and 5 to 35, respectively.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=36 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=15 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=38 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=22 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=7 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=4 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=5 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=2 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Induction Baseline in IBDQ at Week 52
Responders
|
43.9 units on a scale
Standard Deviation 38.06
|
56.4 units on a scale
Standard Deviation 14.52
|
82.3 units on a scale
Standard Deviation 35.59
|
45.3 units on a scale
Standard Deviation 49.89
|
-5.0 units on a scale
Standard Deviation NA
not applicable (1 participant analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in IBDQ at Week 52
Non-responders
|
20.8 units on a scale
Standard Deviation 43.58
|
26.0 units on a scale
Standard Deviation 33.14
|
25.9 units on a scale
Standard Deviation 47.05
|
2.9 units on a scale
Standard Deviation 35.25
|
4.8 units on a scale
Standard Deviation 16.42
|
35.5 units on a scale
Standard Deviation 28.78
|
45.4 units on a scale
Standard Deviation 36.16
|
41.5 units on a scale
Standard Deviation 24.75
|
|
Change From Induction Baseline in IBDQ at Week 52
Clinical responders
|
42.8 units on a scale
Standard Deviation 44.13
|
46.6 units on a scale
Standard Deviation 27.76
|
70.7 units on a scale
Standard Deviation 46.99
|
26.6 units on a scale
Standard Deviation 53.11
|
4.8 units on a scale
Standard Deviation 18.70
|
68.0 units on a scale
Standard Deviation NA
not applicable (1 participant analyzed)
|
34.5 units on a scale
Standard Deviation 4.95
|
24.0 units on a scale
Standard Deviation NA
not applicable (1 participant analyzed)
|
|
Change From Induction Baseline in IBDQ at Week 52
Clinical non-responders
|
9.4 units on a scale
Standard Deviation 31.46
|
13.5 units on a scale
Standard Deviation 19.09
|
9.8 units on a scale
Standard Deviation 30.81
|
-1.5 units on a scale
Standard Deviation 5.81
|
0.0 units on a scale
Standard Deviation 0.00
|
24.6 units on a scale
Standard Deviation 23.17
|
52.7 units on a scale
Standard Deviation 49.03
|
59.0 units on a scale
Standard Deviation NA
not applicable (1 participant analyzed)
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from ITT population with an assessment at given time point. Observed cases.
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. A positive change represents an improvement in health-related quality of life.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=36 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=15 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=38 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=22 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=7 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=4 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=6 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52
Clinical responders
|
0.1435 units on a scale
Standard Deviation 0.1461
|
0.1334 units on a scale
Standard Deviation 0.1740
|
0.2306 units on a scale
Standard Deviation 0.1840
|
0.0587 units on a scale
Standard Deviation 0.1298
|
0.2198 units on a scale
Standard Deviation 0.1615
|
0.4325 units on a scale
Standard Deviation NA
not applicable (1 participant was analyzed)
|
0.1758 units on a scale
Standard Deviation 0.3559
|
0.1316 units on a scale
Standard Deviation NA
not applicable (1 participant was analyzed)
|
|
Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52
Responders
|
0.1350 units on a scale
Standard Deviation 0.1473
|
0.1673 units on a scale
Standard Deviation 0.1090
|
0.2274 units on a scale
Standard Deviation 0.1524
|
0.0122 units on a scale
Standard Deviation 0.1276
|
0.3260 units on a scale
Standard Deviation NA
not applicable (1 participant was analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52
Non-responders
|
0.0208 units on a scale
Standard Deviation 0.2231
|
0.0697 units on a scale
Standard Deviation 0.2091
|
0.1090 units on a scale
Standard Deviation 0.1791
|
0.0449 units on a scale
Standard Deviation 0.1008
|
0.1288 units on a scale
Standard Deviation 0.1674
|
0.1125 units on a scale
Standard Deviation 0.2210
|
0.1542 units on a scale
Standard Deviation 0.2377
|
0.1187 units on a scale
Standard Deviation 0.1128
|
|
Change From Induction Baseline in European Quality of Life (EuroQol) 5 Dimensions Questionnaire (EQ-5D) Index Score at Week 52
Clinical non-responders
|
-0.0577 units on a scale
Standard Deviation 0.2225
|
0.0455 units on a scale
Standard Deviation 0.0643
|
0.0330 units on a scale
Standard Deviation 0.0677
|
-0.0079 units on a scale
Standard Deviation 0.0228
|
0.0000 units on a scale
Standard Deviation 0.0000
|
0.0058 units on a scale
Standard Deviation 0.0708
|
0.1325 units on a scale
Standard Deviation 0.1148
|
0.1122 units on a scale
Standard Deviation 0.1587
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from ITT population with an assessment at given time point. Observed cases.
The EQ-5D is a standardized instrument for use as a measure of health-related quality of life. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in health-related quality of life.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=36 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=15 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=22 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=7 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=4 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=6 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
n=3 Participants
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Induction Baseline in EQ-5D VAS at Week 52
Responders
|
12.9 units on a scale
Standard Deviation 14.65
|
26.9 units on a scale
Standard Deviation 12.80
|
34.8 units on a scale
Standard Deviation 22.55
|
5.0 units on a scale
Standard Deviation 17.80
|
5.0 units on a scale
Standard Deviation NA
not applicable (1 participant was analyzed)
|
—
|
—
|
—
|
|
Change From Induction Baseline in EQ-5D VAS at Week 52
Non-responders
|
12.3 units on a scale
Standard Deviation 24.79
|
11.9 units on a scale
Standard Deviation 18.73
|
13.9 units on a scale
Standard Deviation 27.81
|
4.7 units on a scale
Standard Deviation 14.22
|
12.2 units on a scale
Standard Deviation 16.01
|
17.5 units on a scale
Standard Deviation 16.58
|
20.3 units on a scale
Standard Deviation 21.23
|
0.0 units on a scale
Standard Deviation 15.00
|
|
Change From Induction Baseline in EQ-5D VAS at Week 52
Clinical responders
|
18.2 units on a scale
Standard Deviation 19.19
|
22.2 units on a scale
Standard Deviation 17.16
|
36.1 units on a scale
Standard Deviation 26.19
|
8.1 units on a scale
Standard Deviation 17.95
|
15.6 units on a scale
Standard Deviation 15.63
|
40.0 units on a scale
Standard Deviation NA
not applicable (1 participant was analyzed)
|
11.7 units on a scale
Standard Deviation 16.07
|
-15.0 units on a scale
Standard Deviation NA
not applicable (1 participant was analyzed)
|
|
Change From Induction Baseline in EQ-5D VAS at Week 52
Clinical non-responders
|
3.7 units on a scale
Standard Deviation 21.79
|
5.0 units on a scale
Standard Deviation 7.07
|
0.8 units on a scale
Standard Deviation 11.72
|
-1.0 units on a scale
Standard Deviation 4.24
|
0.0 units on a scale
Standard Deviation 0.00
|
10.0 units on a scale
Standard Deviation 8.66
|
29.0 units on a scale
Standard Deviation 25.36
|
7.5 units on a scale
Standard Deviation 10.61
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from modified ITT population (all randomized participants who took at least 1 dose of study drug in the Induction Period).
Presented as percentage of participants with given number of EIMs at Baseline (BL) and Week (Wk) 52. EIMs of Crohn's disease included anemia, autoimmune hepatitis, axial arthropathy, bronchiectasis, chronic obstructive pulmonary disease, episcleritis, erythema nodosum, iritis, nephrolithiasis, oral aphthous ulcers, peripheral arthropathy, primary sclerosing cholangitis, pyoderma gangrenosum, Sweet's syndrome, uveitis, and venous thromboembolism.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=36 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=36 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=35 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
0 at BL/1 at Wk 52
|
7.1 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
16.0 percentage of participants
|
13.3 percentage of participants
|
10.0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
0 at BL/2 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
0 at BL/missing at Wk 52
|
7.1 percentage of participants
|
0 percentage of participants
|
4.5 percentage of participants
|
8.0 percentage of participants
|
13.3 percentage of participants
|
5.0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
1 at BL/2 at Wk 52
|
7.1 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
11.1 percentage of participants
|
9.1 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
1 at BL/3 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
1 at BL/4 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
2 at BL/2 at Wk 52
|
60.0 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
—
|
50.0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
3 at BL/1 at Wk 52
|
50.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
3 at BL/2 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
—
|
33.3 percentage of participants
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
3 at BL/missing at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
4 at BL/0 at Wk 52
|
0 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
4 at BL/1 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
4 at BL/2 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
4 at BL/4 at Wk 52
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
5 at BL/4 at Wk 52
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
5 at BL/5 at Wk 52
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
4 at BL/3 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
4 at BL/5 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
4 at BL/missing at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
5 at BL/0 at Wk 52
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
5 at BL/1 at Wk 52
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
5 at BL/2 at Wk 52
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
5 at BL/3 at Wk 52
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
3 at BL/3 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
3 at BL/4 at Wk 52
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
3 at BL/5 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
1 at BL/5 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
1 at BL/missing at Wk 52
|
0 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
5 at BL/missing at Wk 52
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
2 at BL/0 at Wk 52
|
20.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
—
|
25.0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
0 at BL/0 at Wk 52
|
85.7 percentage of participants
|
100 percentage of participants
|
86.4 percentage of participants
|
76.0 percentage of participants
|
73.3 percentage of participants
|
85.0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
0 at BL/3 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
0 at BL/4 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
0 at BL/5 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
1 at BL/0 at Wk 52
|
42.9 percentage of participants
|
31.6 percentage of participants
|
40.0 percentage of participants
|
62.5 percentage of participants
|
50.0 percentage of participants
|
54.5 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
1 at BL/1 at Wk 52
|
50.0 percentage of participants
|
57.9 percentage of participants
|
60.0 percentage of participants
|
12.5 percentage of participants
|
33.3 percentage of participants
|
36.4 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
2 at BL/1 at Wk 52
|
0 percentage of participants
|
25.0 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
—
|
25.0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
2 at BL/3 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
2 at BL/4 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
2 at BL/5 at Wk 52
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
2 at BL/missing at Wk 52
|
20.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
|
Cross Tabulation of Induction Baseline and Week 52 in Total Number of Extra-Intestinal Manifestations (EIMs) of Crohn's Disease
3 at BL/0 at Wk 52
|
0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
—
|
66.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from ITT population with isolated ileal Crohn's disease at Induction Baseline. Non responder imputation.
Remission at Week 52 is defined as endoscopic remission at Week 52 AND clinical remission at Week 52. Endoscopic remission: SES-CD ≤ 4 and at least 2-point reduction versus Baseline and no subscore \> 1 in any individual variable. Clinical remission: average daily stool frequency ≤ 1.5 and not worse than Baseline AND average daily abdominal pain ≤ 1.0 and not worse than Baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe). Details of the SES-CD scale are provided in the description of the first primary endpoint.
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=15 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=4 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=7 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=3 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=2 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=2 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=2 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline
Non-responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline
Clinical responders
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline
Responders
|
50.0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline
Clinical non-responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Participants from ITT population with isolated ileal Crohn's disease at Induction Baseline and daily stool frequency \>= 4.0 or daily abdominal pain \>=2.0 at Induction Baseline. Non responder imputation.
Modified clinical remission was defined as average daily stool frequency \<= 2.8 and not worse than induction baseline AND average daily abdominal pain \<= 1.0 and not worse than induction baseline. The very soft/liquid stool frequency and abdominal pain scores at a visit were the average of the daily values reported during the 7 usable days preceding the scheduled assessment visit. Abdominal Pain was rated on a 4-point scale from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Double-Blind Induction Phase: Placebo BID
n=12 Participants
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=3 Participants
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=7 Participants
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 12 mg BID
n=2 Participants
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg BID
n=2 Participants
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: Upadacitinib 24 mg QD
n=2 Participants
Upadacitinib 24 mg once daily (consisting of two 12 mg immediate release \[IR\] doses) during the 16- week double-blind Induction Phase.
|
Upadacitinib 12 mg BID in Extension/Placebo in Induction
n=2 Participants
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase. Placebo in Induction Phase.
|
Upadacitinib 24 mg QD in Extension/Placebo in Induction
Upadacitinib 24 mg QD (consisting of two 12 mg IR doses) during the 36-week double-blind Extension Phase. Placebo in Induction.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Responders
|
66.7 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical non-responders
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Non-responders
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants Who Achieve Modified Clinical Remission at Week 52 Among Participants With Isolated Ileal Crohn's Disease at Baseline And Daily Stool Frequency ≥ 4.0 or Daily Abdominal Pain ≥ 2.0 at Induction Baseline
Clinical responders
|
33.3 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
Adverse Events
Double-Blind Induction Phase: Placebo BID
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Double-Blind Induction Phase: Upadacitinib 3 mg BID
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Double-Blind Induction Phase: Upadacitinib 6 mg BID
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Double Blind Induction Phase: 12 mg BID
Serious events: 10 serious events
Other events: 23 other events
Deaths: 0 deaths
Double Blind Induction Phase: 24 mg BID
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Double Blind Induction Phase: 24 mg QD
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
Double Blind Extension Phase: 3 mg BID
Serious events: 18 serious events
Other events: 31 other events
Deaths: 0 deaths
Double Blind Extension Phase: 6 mg BID
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Double Blind Extension 12 mg BID
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Double Blind Extension 24 mg QD
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Open Label Extension Subjects Never Received OL 24 mg BID
Serious events: 11 serious events
Other events: 8 other events
Deaths: 0 deaths
Open Label Extension Subjects Received OL 24 mg BID
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 participants at risk
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 participants at risk
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 participants at risk
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: 12 mg BID
n=36 participants at risk
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: 24 mg BID
n=36 participants at risk
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: 24 mg QD
n=35 participants at risk
Upadacitinib 24 mg QD during the 16-week double-blind Induction Phase.
|
Double Blind Extension Phase: 3 mg BID
n=60 participants at risk
Upadacitinib 3 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: 6 mg BID
n=23 participants at risk
Upadacitinib 6 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension 12 mg BID
n=59 participants at risk
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase.
(Participants in this arm who met inadequate response criteria at or after Week 20 and switched to OL 12 mg BID are included.)
|
Double Blind Extension 24 mg QD
n=36 participants at risk
Upadacitinib 24 mg BID during the 36-week double-blind Extension Phase.
|
Open Label Extension Subjects Never Received OL 24 mg BID
n=33 participants at risk
Participants from the Double Blind Extension 3 mg, 6 mg, and 24 mg arms who met inadequate response criteria at or after Week 20 and switched to OL 12 mg BID.
|
Open Label Extension Subjects Received OL 24 mg BID
n=27 participants at risk
Participants from the Double Blind Extension 3 mg, 6 mg, 12 mg, and 24 mg arms who met inadequate response criteria at or after Week 20 and switched to OL 12 mg BID and then further dose escalated to OL 24 mg BID.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Cardiac disorders
PULSELESS ELECTRICAL ACTIVITY
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.7%
7/60 • Number of events 8 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.4%
2/59 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
4/36 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
21.2%
7/33 • Number of events 9 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
FISTULA OF SMALL INTESTINE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
GASTROINTESTINAL OBSTRUCTION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ILEAL PERFORATION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
INTESTINAL FISTULA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
INTESTINAL STENOSIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
MESENTERIC VEIN THROMBOSIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
PERITONEAL ADHESIONS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.3%
2/60 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
General disorders
CHEST PAIN
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
ABSCESS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
RECTAL ABSCESS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM OF THYMUS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
Other adverse events
| Measure |
Double-Blind Induction Phase: Placebo BID
n=37 participants at risk
Placebo BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 3 mg BID
n=39 participants at risk
Upadacitinib 3 mg BID during the 16-week double-blind Induction Phase.
|
Double-Blind Induction Phase: Upadacitinib 6 mg BID
n=37 participants at risk
Upadacitinib 6 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: 12 mg BID
n=36 participants at risk
Upadacitinib 12 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: 24 mg BID
n=36 participants at risk
Upadacitinib 24 mg BID during the 16-week double-blind Induction Phase.
|
Double Blind Induction Phase: 24 mg QD
n=35 participants at risk
Upadacitinib 24 mg QD during the 16-week double-blind Induction Phase.
|
Double Blind Extension Phase: 3 mg BID
n=60 participants at risk
Upadacitinib 3 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension Phase: 6 mg BID
n=23 participants at risk
Upadacitinib 6 mg BID during the 36-week double-blind Extension Phase.
|
Double Blind Extension 12 mg BID
n=59 participants at risk
Upadacitinib 12 mg BID during the 36-week double-blind Extension Phase.
(Participants in this arm who met inadequate response criteria at or after Week 20 and switched to OL 12 mg BID are included.)
|
Double Blind Extension 24 mg QD
n=36 participants at risk
Upadacitinib 24 mg BID during the 36-week double-blind Extension Phase.
|
Open Label Extension Subjects Never Received OL 24 mg BID
n=33 participants at risk
Participants from the Double Blind Extension 3 mg, 6 mg, and 24 mg arms who met inadequate response criteria at or after Week 20 and switched to OL 12 mg BID.
|
Open Label Extension Subjects Received OL 24 mg BID
n=27 participants at risk
Participants from the Double Blind Extension 3 mg, 6 mg, 12 mg, and 24 mg arms who met inadequate response criteria at or after Week 20 and switched to OL 12 mg BID and then further dose escalated to OL 24 mg BID.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
General disorders
CHILLS
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
12.8%
5/39 • Number of events 6 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
16.7%
6/36 • Number of events 8 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
14.3%
5/35 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.7%
4/60 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.0%
3/60 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
ANORECTAL DISCOMFORT
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
16.2%
6/37 • Number of events 6 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
15.4%
6/39 • Number of events 6 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
10.8%
4/37 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
19.4%
7/36 • Number of events 8 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
10.0%
6/60 • Number of events 6 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.7%
2/23 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
10.2%
6/59 • Number of events 7 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.1%
2/33 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
3/27 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.1%
3/37 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
FLATULENCE
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.4%
2/59 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
NAUSEA
|
8.1%
3/37 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.1%
3/37 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
3/59 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.7%
3/39 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Gastrointestinal disorders
VOMITING
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
10.3%
4/39 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
3/59 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.0%
1/33 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
General disorders
FATIGUE
|
8.1%
3/37 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
20.5%
8/39 • Number of events 9 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
4/36 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.3%
2/60 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.4%
2/59 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.0%
3/60 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
General disorders
PYREXIA
|
8.1%
3/37 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
12.8%
5/39 • Number of events 6 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
3/59 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
GASTROENTERITIS
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.7%
3/39 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.8%
4/59 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
3/59 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
SINUSITIS
|
2.7%
1/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.7%
2/23 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/59 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
4/36 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
4/36 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.0%
3/60 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.8%
4/59 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
10.8%
4/37 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
13.9%
5/36 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.7%
4/60 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.5%
5/59 • Number of events 6 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
2.7%
1/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
10.3%
4/39 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
10.8%
4/37 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
4/36 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
5/60 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.9%
7/59 • Number of events 8 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.7%
4/60 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.4%
2/59 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.0%
3/60 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.8%
4/37 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.6%
3/35 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
5/60 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
3.4%
2/59 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.9%
1/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Nervous system disorders
HEADACHE
|
8.1%
3/37 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
17.9%
7/39 • Number of events 8 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
18.9%
7/37 • Number of events 11 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
22.2%
8/36 • Number of events 9 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
14.3%
5/35 • Number of events 5 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.5%
5/59 • Number of events 6 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Psychiatric disorders
ANXIETY
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.0%
3/60 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
7.7%
3/39 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.0%
3/60 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
3/59 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.3%
3/36 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.6%
3/35 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
1.7%
1/60 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.8%
4/59 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
8.6%
3/35 • Number of events 4 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
4.3%
1/23 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
3/59 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
6.1%
2/33 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.6%
2/36 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.7%
1/37 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/35 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/37 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/39 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.4%
2/37 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
2.8%
1/36 • Number of events 1 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
5.7%
2/35 • Number of events 2 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/60 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/23 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/59 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/36 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/33 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
0.00%
0/27 • Treatment-emergent adverse events AEs (TEAEs): collected from the first dose of study drug through Week 52 plus 30 days.
For the Extension Phase, a TEAE was defined as any AE with an onset date on or after the first dose of double-blind Extension dose and prior to the open-label dose or up to 30 days after the last dose of double-blind Extension dose if subject discontinued prematurely in the double-blind Extension Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER