Trial Outcomes & Findings for A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission (NCT NCT03281304)
NCT ID: NCT03281304
Last Updated: 2023-03-21
Results Overview
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Month 6
Results posted on
2023-03-21
Participant Flow
The study enrolled participants from A3921139 (NCT01470612) who were on tofacitinib 10 milligram (mg) twice daily (BID) for at least 2 consecutive years, who were in stable remission for at least 6 months prior to baseline of A3921288 and who were not receiving any corticosteroid treatment to treat their ulcerative colitis (UC) for at least 4 weeks prior to enrollment.
The Baseline visit of this study was the last visit in study A3921139. All procedures done at the last visit in A3921139 for participants enrolled into this study were used as the Baseline data for this study.
Participant milestones
| Measure |
Tofacitinib 5 mg BID
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Treatment Phase (up to 42 Months)
STARTED
|
70
|
70
|
|
Treatment Phase (up to 42 Months)
COMPLETED
|
36
|
27
|
|
Treatment Phase (up to 42 Months)
NOT COMPLETED
|
34
|
43
|
|
Follow-up Phase (up to 4 Weeks)
STARTED
|
63
|
57
|
|
Follow-up Phase (up to 4 Weeks)
COMPLETED
|
61
|
56
|
|
Follow-up Phase (up to 4 Weeks)
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Tofacitinib 5 mg BID
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Treatment Phase (up to 42 Months)
Adverse Event
|
10
|
10
|
|
Treatment Phase (up to 42 Months)
Lack of Efficacy
|
3
|
2
|
|
Treatment Phase (up to 42 Months)
Pregnancy
|
1
|
0
|
|
Treatment Phase (up to 42 Months)
Withdrawal by Subject
|
5
|
12
|
|
Treatment Phase (up to 42 Months)
Death
|
0
|
1
|
|
Treatment Phase (up to 42 Months)
Study terminated by sponsor
|
15
|
16
|
|
Treatment Phase (up to 42 Months)
Other
|
0
|
2
|
|
Follow-up Phase (up to 4 Weeks)
Other
|
2
|
1
|
Baseline Characteristics
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Baseline characteristics by cohort
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Remission Based on Modified Mayo Score at Month 6
|
54 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Up to Month 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \>=1 point and increase in endoscopic subscore by \>=1 point; increase from Baseline in rectal bleeding subscore by \>=2 points and endoscopic subscore \>0; increase in stool frequency subscore by \>=2 points and increase in endoscopic subscore by \>=1 point; increase in endoscopic subscore by \>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
|
NA Days
Interval 29.0 to 1268.0
Median was not estimated due to insufficient number of participants with the event.
|
1270 Days
Interval 28.0 to 1270.0
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 1
|
62 Participants
|
64 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 3
|
57 Participants
|
65 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 6
|
57 Participants
|
67 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 9
|
52 Participants
|
66 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 12
|
50 Participants
|
61 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 15
|
48 Participants
|
58 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 18
|
45 Participants
|
55 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 21
|
46 Participants
|
51 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 24
|
47 Participants
|
51 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 27
|
43 Participants
|
49 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 30
|
44 Participants
|
46 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 33
|
42 Participants
|
43 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 36
|
42 Participants
|
44 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 39
|
40 Participants
|
37 Participants
|
|
Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 42
|
26 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Months 6, 18, 30 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Month 6
|
53 Participants
|
61 Participants
|
|
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Month 18
|
33 Participants
|
47 Participants
|
|
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Month 30
|
35 Participants
|
44 Participants
|
|
Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
Month 42
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 1
|
62 Participants
|
64 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 3
|
57 Participants
|
65 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 6
|
56 Participants
|
66 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 9
|
52 Participants
|
66 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 12
|
50 Participants
|
61 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 15
|
48 Participants
|
58 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 18
|
44 Participants
|
55 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 21
|
46 Participants
|
50 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 24
|
46 Participants
|
51 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 27
|
42 Participants
|
49 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 30
|
43 Participants
|
46 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 33
|
42 Participants
|
43 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 36
|
42 Participants
|
44 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 39
|
39 Participants
|
37 Participants
|
|
Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Month 42
|
26 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Months 18, 30 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
Month 18
|
37 Participants
|
48 Participants
|
|
Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
Month 30
|
35 Participants
|
44 Participants
|
|
Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
Month 42
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=67 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=68 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Modified Mayo Score at Month 6
|
0.6 Units on a scale
Standard Error 0.2
|
0.3 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline, Months 18, 30 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=48 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=57 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Change at Month 18
|
0.5 Units on a scale
Standard Deviation 1.3
|
0.3 Units on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Change at Month 30
|
0.3 Units on a scale
Standard Deviation 1.2
|
0.1 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
Change at Month 42
|
0.3 Units on a scale
Standard Deviation 0.9
|
0.2 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3 and 6Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=67 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=69 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Change at Month 1
|
0.1 Units on a scale
Standard Error 0.1
|
0.2 Units on a scale
Standard Error 0.1
|
|
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Change at Month 3
|
0.2 Units on a scale
Standard Error 0.1
|
0.1 Units on a scale
Standard Error 0.1
|
|
Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
Change at Month 6
|
0.1 Units on a scale
Standard Error 0.1
|
0.2 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=53 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=67 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 33
|
0.0 Units on a scale
Standard Deviation 0.4
|
0.2 Units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 9
|
0.1 Units on a scale
Standard Deviation 0.7
|
0.1 Units on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 12
|
0.1 Units on a scale
Standard Deviation 0.5
|
0.1 Units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 15
|
0.2 Units on a scale
Standard Deviation 0.8
|
0.1 Units on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 18
|
0.1 Units on a scale
Standard Deviation 0.6
|
0.1 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 21
|
0.1 Units on a scale
Standard Deviation 0.5
|
0.2 Units on a scale
Standard Deviation 1.1
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 24
|
0.0 Units on a scale
Standard Deviation 0.5
|
0.0 Units on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 27
|
0.1 Units on a scale
Standard Deviation 0.5
|
0.1 Units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 30
|
0.1 Units on a scale
Standard Deviation 0.7
|
0.0 Units on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 36
|
0.0 Units on a scale
Standard Deviation 0.5
|
0.0 Units on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 39
|
0.0 Units on a scale
Standard Deviation 0.5
|
0.0 Units on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 42
|
0.1 Units on a scale
Standard Deviation 0.4
|
0.1 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=67 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=68 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Total Mayo Score at Month 6
|
0.9 Units on a scale
Standard Error 0.2
|
0.4 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, Months 18, 30 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed"= participants evaluable for this outcome measure at specified time points.
Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=48 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=57 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Change at Month 18
|
0.7 Units on a scale
Standard Deviation 1.7
|
0.4 Units on a scale
Standard Deviation 1.9
|
|
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Change at Month 30
|
0.4 Units on a scale
Standard Deviation 1.4
|
0.1 Units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Total Mayo Score at Months 18, 30 and 42
Change at Month 42
|
0.4 Units on a scale
Standard Deviation 1.2
|
0.2 Units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3 and 6Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Change at Month 1
|
0.2 Units on a scale
Standard Error 0.1
|
0.2 Units on a scale
Standard Error 0.1
|
|
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Change at Month 3
|
0.3 Units on a scale
Standard Error 0.1
|
0.2 Units on a scale
Standard Error 0.1
|
|
Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
Change at Month 6
|
0.3 Units on a scale
Standard Error 0.1
|
0.3 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=53 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=67 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 9
|
0.2 Units on a scale
Standard Deviation 0.8
|
0.2 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 12
|
0.1 Units on a scale
Standard Deviation 0.7
|
0.2 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 15
|
0.3 Units on a scale
Standard Deviation 1.2
|
0.1 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 18
|
0.2 Units on a scale
Standard Deviation 0.8
|
0.2 Units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 21
|
0.1 Units on a scale
Standard Deviation 0.7
|
0.4 Units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 24
|
0.1 Units on a scale
Standard Deviation 0.6
|
0.0 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 27
|
0.1 Units on a scale
Standard Deviation 0.6
|
0.1 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 30
|
0.2 Units on a scale
Standard Deviation 0.8
|
0.1 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 33
|
0.0 Units on a scale
Standard Deviation 0.5
|
0.2 Units on a scale
Standard Deviation 1.0
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 36
|
0.0 Units on a scale
Standard Deviation 0.6
|
-0.1 Units on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 39
|
0.1 Units on a scale
Standard Deviation 0.6
|
-0.1 Units on a scale
Standard Deviation 0.6
|
|
Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 42
|
0.1 Units on a scale
Standard Deviation 0.5
|
0.2 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Months 6, 18, 30 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Month 6
|
56 Participants
|
64 Participants
|
|
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Month 18
|
43 Participants
|
56 Participants
|
|
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Month 30
|
38 Participants
|
47 Participants
|
|
Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
Month 42
|
36 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Months 6, 18, 30 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.
Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Month 6
|
59 Participants
|
67 Participants
|
|
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Month 18
|
42 Participants
|
50 Participants
|
|
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Month 30
|
41 Participants
|
48 Participants
|
|
Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
Month 42
|
26 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Change from baseline in fecal calprotectin (in micrograms per gram \[mcg/g\]) was reported.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=63 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=67 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 1
|
-137.5 Micrograms per gram
Standard Deviation 980.6
|
-21.9 Micrograms per gram
Standard Deviation 304.7
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 3
|
-45.3 Micrograms per gram
Standard Deviation 1075.8
|
-38.5 Micrograms per gram
Standard Deviation 313.6
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 6
|
-24.1 Micrograms per gram
Standard Deviation 1444.6
|
-47.3 Micrograms per gram
Standard Deviation 331.4
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 9
|
-173.5 Micrograms per gram
Standard Deviation 1106.5
|
-59.3 Micrograms per gram
Standard Deviation 380.8
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 12
|
-28.8 Micrograms per gram
Standard Deviation 1113.4
|
-45.0 Micrograms per gram
Standard Deviation 350.7
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 15
|
-104.8 Micrograms per gram
Standard Deviation 1210.2
|
69.3 Micrograms per gram
Standard Deviation 480.5
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 18
|
-51.0 Micrograms per gram
Standard Deviation 1114.6
|
6.6 Micrograms per gram
Standard Deviation 565.4
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 21
|
-71.0 Micrograms per gram
Standard Deviation 1254.6
|
-29.3 Micrograms per gram
Standard Deviation 462.7
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 24
|
118.3 Micrograms per gram
Standard Deviation 1591.4
|
-69.8 Micrograms per gram
Standard Deviation 407.0
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 27
|
87.3 Micrograms per gram
Standard Deviation 478.8
|
-49.1 Micrograms per gram
Standard Deviation 366.3
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 30
|
-8.5 Micrograms per gram
Standard Deviation 458.5
|
-8.9 Micrograms per gram
Standard Deviation 518.5
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 33
|
84.4 Micrograms per gram
Standard Deviation 434.5
|
-4.9 Micrograms per gram
Standard Deviation 484.8
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 36
|
230.7 Micrograms per gram
Standard Deviation 1162.5
|
-0.4 Micrograms per gram
Standard Deviation 449.4
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 39
|
-116.2 Micrograms per gram
Standard Deviation 472.8
|
-98.3 Micrograms per gram
Standard Deviation 532.9
|
|
Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 42
|
-44.7 Micrograms per gram
Standard Deviation 278.9
|
-101.0 Micrograms per gram
Standard Deviation 452.0
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42Population: Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Change From baseline in hs-CRP level (in milligrams per liter \[mg/L\]) is reported.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=63 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=67 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 1
|
1.1 Milligrams per liter
Standard Deviation 9.8
|
-0.7 Milligrams per liter
Standard Deviation 3.4
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 3
|
0.7 Milligrams per liter
Standard Deviation 7.9
|
-0.2 Milligrams per liter
Standard Deviation 3.7
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 6
|
0.9 Milligrams per liter
Standard Deviation 5.8
|
0.1 Milligrams per liter
Standard Deviation 4.0
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 9
|
0.7 Milligrams per liter
Standard Deviation 11.1
|
1.1 Milligrams per liter
Standard Deviation 8.4
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 12
|
-0.3 Milligrams per liter
Standard Deviation 3.5
|
-0.2 Milligrams per liter
Standard Deviation 2.2
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 15
|
-0.7 Milligrams per liter
Standard Deviation 3.2
|
0.2 Milligrams per liter
Standard Deviation 2.4
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 18
|
1.0 Milligrams per liter
Standard Deviation 6.4
|
0.2 Milligrams per liter
Standard Deviation 1.9
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 21
|
-0.5 Milligrams per liter
Standard Deviation 3.3
|
-0.1 Milligrams per liter
Standard Deviation 1.4
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 24
|
-0.6 Milligrams per liter
Standard Deviation 3.0
|
-0.5 Milligrams per liter
Standard Deviation 2.2
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 27
|
-0.3 Milligrams per liter
Standard Deviation 2.8
|
0.7 Milligrams per liter
Standard Deviation 6.1
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 30
|
0.6 Milligrams per liter
Standard Deviation 4.1
|
-0.3 Milligrams per liter
Standard Deviation 1.9
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 33
|
0.1 Milligrams per liter
Standard Deviation 2.2
|
0.0 Milligrams per liter
Standard Deviation 3.9
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 36
|
-0.1 Milligrams per liter
Standard Deviation 3.1
|
-0.1 Milligrams per liter
Standard Deviation 3.9
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 39
|
-0.3 Milligrams per liter
Standard Deviation 3.5
|
2.8 Milligrams per liter
Standard Deviation 8.6
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
Change at Month 42
|
0.6 Milligrams per liter
Standard Deviation 3.7
|
5.9 Milligrams per liter
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: Baseline up to 43 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of investigational product.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
55 Participants
|
58 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
7 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 43 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of investigational product.
Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Serious Infections
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 27 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of investigational product.
Abnormality criteria: Hematology: hemoglobin(Hg): \<0.8\* lower limit of normal (LLN); hematocrit: \<0.8\*LLN; lymphocytes: \<0.8\* LLN; lymphocytes/leukocytes: \<0.8\*LLN; erythrocytes: \<0.8\*LLN; erythrocytes mean corpuscular volume: \<0.9\*LLN; erythrocytes mean corpuscular Hg: \<0.9\*LLN; reticulocytes, reticulocytes/erythrocytes:\>1.5\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \>1.2\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \>1.2\*ULN; leukocyte esterase: \>=1; Clinical chemistry: bicarbonate:\<0.9\*LLN, bilirubin: \>1.5\*ULN; indirect bilirubin: \>1.5\* ULN; aspartate aminotransferase(AT): \>3.0\*ULN; alanine AT: \>3.0\*ULN; gamma glutamyl transferase: \>3.0\* ULN; creatine kinase: \>2.0\*ULN; potassium: \>1.1\*ULN; blood urea nitrogen: \>1.3\*ULN; creatinine: \>1.3\*ULN; urate: \>1.2\*ULN; cholesterol: \>1.3\*ULN; HDL-cholesterol: \<0.8\* LLN; LDL-cholesterol: \>1.2\*ULN; triglycerides: \>1.3\*ULN; glucose: \>1.5\*ULN; and urine Hg \>=1.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
|
33 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 43 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of investigational product.
Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \<750 neutrophils per cubic millimeter (mm\^3); 2 sequential lymphocyte counts \<500 lymphocytes/mm\^3; 2 sequential hemoglobin \<8.0 grams per deciliter; 2 sequential platelet counts \<75000 platelets/mm\^3; 2 sequential AST or ALT elevations \>=3\*ULN with at least one total bilirubin value \>=2\*ULN; 2 sequential AST or ALT elevations \>=3\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \>=5\*ULN; 2 sequential increases in creatinine \>50% and \>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \>10\*ULN unless the causality is known not to be medically serious (eg, exercise induced).
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 43 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of investigational product.
Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \<50 millimeter of mercury (mmHg), b) change greater than equal to (\>=) 20 mmHg increase, c) change \>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \<90 mmHg, b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate \>120 bpm. Only those categories in which at least 1 participant had data were reported.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Vital Sign Abnormalities
DBP: <50 mmHg
|
3 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
DBP: Change >= 20mmHg increase
|
9 Participants
|
5 Participants
|
|
Number of Participants With Vital Sign Abnormalities
DBP: Change >= 20mmHg decrease
|
7 Participants
|
7 Participants
|
|
Number of Participants With Vital Sign Abnormalities
SBP: <90mmHg
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities
SBP: Change >= 30mmHg increase
|
7 Participants
|
4 Participants
|
|
Number of Participants With Vital Sign Abnormalities
SBP: Change >= 30mmHg decrease
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 43 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of investigational product.
Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Clinically Significant Physical Examinations Abnormalities
|
28 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 43 monthsPopulation: Safety analysis set included all participants who received at least 1 dose of investigational product.
Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.
Outcome measures
| Measure |
Tofacitinib 5 mg BID
n=70 Participants
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 Participants
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
|---|---|---|
|
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Opportunistic Infections
|
0 Participants
|
1 Participants
|
|
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
All Malignancy
|
4 Participants
|
3 Participants
|
|
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Gastrointestinal Perforation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
Cardiovascular Events
|
2 Participants
|
2 Participants
|
Adverse Events
Tofacitinib 5 mg BID
Serious events: 7 serious events
Other events: 47 other events
Deaths: 0 deaths
Tofacitinib 10 mg BID
Serious events: 16 serious events
Other events: 47 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tofacitinib 5 mg BID
n=70 participants at risk
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 participants at risk
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed-up to 4 weeks after the last dose.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Breast disorder
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Colon dysplasia
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Appendicitis
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
Other adverse events
| Measure |
Tofacitinib 5 mg BID
n=70 participants at risk
Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.
|
Tofacitinib 10 mg BID
n=70 participants at risk
Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed-up to 4 weeks after the last dose.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
22.9%
16/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
20.0%
14/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
General disorders
Oedema peripheral
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Herpes zoster
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Influenza
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
7/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
11.4%
8/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Oral herpes
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
5.7%
4/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Investigations
Faecal calprotectin increased
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Investigations
Lymphocyte count decreased
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
4/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Headache
|
5.7%
4/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Hypertension
|
5.7%
4/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
4/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
General disorders
Chest pain
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
General disorders
Fatigue
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
General disorders
Pyrexia
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Clostridium difficile infection
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Sinusitis
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Investigations
SARS-CoV-2 test positive
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
10.0%
7/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
4/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
7.1%
5/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
3/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.9%
2/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
0.00%
0/70 • From baseline up to 4 weeks after last dose (maximum up to 43 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER