Trial Outcomes & Findings for Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs) (NCT NCT03970837)
NCT ID: NCT03970837
Last Updated: 2023-11-30
Results Overview
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1764 participants
Primary outcome timeframe
Week 12
Results posted on
2023-11-30
Participant Flow
For both Global and Asia cohorts, participants were randomized in a ratio of 6:6:3:1:1:1 to GSK3196165 90 milligram (mg):GSK3196165 150mg:Tofacitinib 5mg:Placebo:Placebo:Placebo. At Week 12, participants randomized to three placebo arms switched to active intervention arms (GSK3196165 90mg, 150mg or Tofacitinib 5mg), receiving the active intervention for 40 weeks. Participants who were randomized to active intervention arms from study day 1, received the active intervention for 52 weeks.
Total of 1764 participants were enrolled in the study (1625 in Global and 139 in Asia cohorts which is supplementary to Global Cohort). One participant from GSK3196165 150mg (Asia cohort) arm was randomized but not treated. The study was terminated early only for Asia Cohort as the limited efficacy did not support the benefit risk profile of Otilimab as a potential treatment.
Participant milestones
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
GSK3196165 90mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
GSK3196165 150mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
545
|
539
|
271
|
91
|
89
|
90
|
47
|
49
|
19
|
6
|
8
|
9
|
|
Overall Study
Safety Set
|
545
|
539
|
286
|
0
|
0
|
0
|
47
|
49
|
19
|
0
|
0
|
0
|
|
Overall Study
Safety Set-Placebo Switch
|
0
|
0
|
0
|
85
|
80
|
67
|
0
|
0
|
0
|
6
|
8
|
8
|
|
Overall Study
COMPLETED
|
461
|
447
|
231
|
73
|
69
|
68
|
25
|
23
|
15
|
4
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
84
|
92
|
40
|
18
|
20
|
22
|
22
|
26
|
4
|
2
|
3
|
5
|
Reasons for withdrawal
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
GSK3196165 90mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
GSK3196165 150mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)
Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
23
|
20
|
16
|
6
|
4
|
5
|
1
|
5
|
0
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
14
|
12
|
1
|
2
|
3
|
4
|
6
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
5
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
5
|
8
|
4
|
1
|
5
|
2
|
4
|
5
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
32
|
35
|
12
|
8
|
6
|
8
|
2
|
3
|
0
|
0
|
0
|
1
|
|
Overall Study
PROTOCOL-SPECIFIED WITHDRAWAL CRITERION MET
|
3
|
12
|
2
|
0
|
2
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
STUDY TERMINATED BY SPONSOR
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
11
|
2
|
1
|
2
|
3
|
Baseline Characteristics
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
Baseline characteristics by cohort
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
GSK3196165 90mg + csDMARD (Asia Cohort)
n=47 Participants
Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
GSK3196165 150mg + csDMARD (Asia Cohort)
n=49 Participants
Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Asia Cohort)
n=19 Participants
Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)
n=6 Participants
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)
n=8 Participants
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)
n=9 Participants
Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
Total
n=1763 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-49 Years
|
172 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
21 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
528 Participants
n=36 Participants
|
|
Age, Customized
50-64 Years
|
254 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
22 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
847 Participants
n=36 Participants
|
|
Age, Customized
>=65 Years
|
119 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
388 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
431 Participants
n=5 Participants
|
430 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
73 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
37 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
1403 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
360 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
29 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
105 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
49 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
429 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
24 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
409 Participants
n=5 Participants
|
393 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
67 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1202 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
MISSING
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The analysis was performed on the Intent-to-Treat (ITT) set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo (Global Cohort)
|
54.9 Percentage of participants
|
54.5 Percentage of participants
|
71.1 Percentage of participants
|
32.5 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: ITT-Supplementary Asia Cohort Population consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=44 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage (%) of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 (Asia Cohort)
|
45.0 Percentage of participants
|
40.0 Percentage of participants
|
68.0 Percentage of participants
|
14.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Global Cohort)
|
26.5 Percentage of participants
|
25.1 Percentage of participants
|
36.8 Percentage of participants
|
11.4 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Global Cohort)
|
-0.32 Scores on a scale
Standard Error 0.029
|
-0.31 Scores on a scale
Standard Error 0.029
|
-0.46 Scores on a scale
Standard Error 0.037
|
-0.14 Scores on a scale
Standard Error 0.038
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) \[visual analogue scale (VAS) with values from 0=best to 100=worst\], Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant \[high sensitivity C-reactive Protein milligram per liter (mg/L) (hsCRP)\].
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving 20% Improvement in ACR20 at Week 24: Non-inferiority Comparison With Tofacitinib (Global Cohort)
|
65.0 Percentage of participants
|
62.5 Percentage of participants
|
79.8 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
32.8 Percentage of participants
|
34.3 Percentage of participants
|
49.6 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
38.3 Percentage of participants
|
38.0 Percentage of participants
|
56.8 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
37.5 Percentage of participants
|
15.9 Percentage of participants
|
46.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
40.2 Percentage of participants
|
38.2 Percentage of participants
|
41.3 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Global Cohort)
|
4.7 Percentage of participants
|
4.5 Percentage of participants
|
9.7 Percentage of participants
|
3.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
6.9 Percentage of participants
|
7.2 Percentage of participants
|
17.9 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
11.9 Percentage of participants
|
10.8 Percentage of participants
|
21.2 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
11.4 Percentage of participants
|
5.6 Percentage of participants
|
17.2 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
6.6 Percentage of participants
|
5.7 Percentage of participants
|
11.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
ACR50/70 is calculated as a 50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Global Cohort)
ACR50
|
21.6 Percentage of participants
|
25.1 Percentage of participants
|
39.4 Percentage of participants
|
9.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Global Cohort)
ACR70
|
6.9 Percentage of participants
|
9.6 Percentage of participants
|
18.9 Percentage of participants
|
4.2 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20%/50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)\].
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
ACR20, Week 52
|
64.3 Percentage of participants
|
65.3 Percentage of participants
|
75.6 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
ACR50, Week 24
|
31.6 Percentage of participants
|
32.8 Percentage of participants
|
53.6 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
ACR50, Week 52
|
36.5 Percentage of participants
|
36.9 Percentage of participants
|
52.9 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
ACR70, Week 24
|
14.0 Percentage of participants
|
13.0 Percentage of participants
|
28.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
ACR70, Week 52
|
19.1 Percentage of participants
|
17.5 Percentage of participants
|
35.7 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)\].
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)
ACR20, Week 52
|
56.3 Percentage of participants
|
63.4 Percentage of participants
|
70.1 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)
ACR50, Week 24
|
35.6 Percentage of participants
|
27.6 Percentage of participants
|
41.8 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)
ACR50, Week 52
|
43.7 Percentage of participants
|
38.5 Percentage of participants
|
47.2 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)
ACR70, Week 24
|
18.7 Percentage of participants
|
10.5 Percentage of participants
|
21.8 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR50/70 at Week 24 and ACR20/50/70 Week 52 for Placebo Switched Arms (Global Cohort)
ACR70, Week 52
|
22.6 Percentage of participants
|
15.4 Percentage of participants
|
20.7 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Global Cohort)
|
23.2 Percentage of participants
|
23.6 Percentage of participants
|
40.7 Percentage of participants
|
10.4 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Global Cohort)
|
13.2 Percentage of participants
|
14.6 Percentage of participants
|
23.6 Percentage of participants
|
7.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
31.3 Percentage of participants
|
33.0 Percentage of participants
|
55.3 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
35.4 Percentage of participants
|
36.4 Percentage of participants
|
53.9 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
19.9 Percentage of participants
|
24.1 Percentage of participants
|
37.1 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
26.2 Percentage of participants
|
22.9 Percentage of participants
|
38.8 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
41.4 Percentage of participants
|
31.4 Percentage of participants
|
39.6 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
37.5 Percentage of participants
|
19.3 Percentage of participants
|
42.7 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
30.2 Percentage of participants
|
14.2 Percentage of participants
|
23.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
28.0 Percentage of participants
|
16.6 Percentage of participants
|
31.5 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (\<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Global Cohort)
|
11.5 Percentage of participants
|
12.0 Percentage of participants
|
23.2 Percentage of participants
|
5.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Global Cohort)
|
7.1 Percentage of participants
|
6.1 Percentage of participants
|
12.6 Percentage of participants
|
3.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (\<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
16.7 Percentage of participants
|
19.6 Percentage of participants
|
38.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
23.6 Percentage of participants
|
21.2 Percentage of participants
|
41.2 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
8.7 Percentage of participants
|
11.7 Percentage of participants
|
23.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
14.3 Percentage of participants
|
11.7 Percentage of participants
|
19.9 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (\<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
23.3 Percentage of participants
|
11.5 Percentage of participants
|
23.8 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
30.4 Percentage of participants
|
19.8 Percentage of participants
|
26.4 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
13.4 Percentage of participants
|
6.2 Percentage of participants
|
13.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
16.1 Percentage of participants
|
11.5 Percentage of participants
|
13.4 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; DAS28\<=3.2 and DAS28 decrease from Baseline (\>1.2: good response),(\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response); DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline (\>1.2: moderate response),(\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response) and DAS28\>5.1 and DAS28 decrease from Baseline (\>1.2: moderate response),(\>0.6 to \<=1.2: no response) and (\<=0.6: no response).If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Good/Moderate (European League Against Rheumatism) EULAR Response at Week 12 (Global Cohort)
|
70.0 Percentage of participants
|
71.3 Percentage of participants
|
83.8 Percentage of participants
|
46.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 \<=3.2 and DAS28 decrease from Baseline (\>1.2: good response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response); if current DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response) and if current DAS28 \>5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: no response) and (\<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
79.8 Percentage of participants
|
80.5 Percentage of participants
|
90.4 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
80.3 Percentage of participants
|
78.9 Percentage of participants
|
88.4 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 \<=3.2 and DAS28 decrease from Baseline (\>1.2: good response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response); if current DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response) and if current DAS28 \>5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: no response) and (\<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
78.4 Percentage of participants
|
73.0 Percentage of participants
|
82.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
74.5 Percentage of participants
|
81.1 Percentage of participants
|
81.5 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the specified time points were analyzed.
Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving ACR/EULAR Remission at Week 12 (Global Cohort)
|
13 Participants
|
12 Participants
|
15 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the specified time points were analyzed.
Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=497 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=477 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=247 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
21 Participants
|
18 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
37 Participants
|
26 Participants
|
27 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Only those participants with data available at the specified time points were analyzed.
Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=83 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=75 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=76 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
8 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of \<=0.5. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Global Cohort)
|
88.2 Percentage of participants
|
92.7 Percentage of participants
|
94.1 Percentage of participants
|
85.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of \<=0.5.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
84.6 Percentage of participants
|
89.9 Percentage of participants
|
92.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
78.2 Percentage of participants
|
83.8 Percentage of participants
|
87.7 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of \<=0.5.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
88.1 Percentage of participants
|
82.2 Percentage of participants
|
83.9 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
85.6 Percentage of participants
|
71.9 Percentage of participants
|
87.9 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (PtGA and PhGA VAS with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CDAI Total Score at Week 12 (Global Cohort)
|
-15.50 Scores on a scale
Standard Error 0.680
|
-16.31 Scores on a scale
Standard Error 0.678
|
-21.06 Scores on a scale
Standard Error 0.878
|
-9.56 Scores on a scale
Standard Error 0.896
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV).
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
-20.14 Scores on a scale
Standard Error 0.669
|
-20.68 Scores on a scale
Standard Error 0.677
|
-24.93 Scores on a scale
Standard Error 0.848
|
—
|
—
|
—
|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
-20.84 Scores on a scale
Standard Error 0.750
|
-21.14 Scores on a scale
Standard Error 0.762
|
-24.87 Scores on a scale
Standard Error 0.936
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
-20.26 Scores on a scale
Standard Error 1.334
|
-16.78 Scores on a scale
Standard Error 1.396
|
-20.60 Scores on a scale
Standard Error 1.385
|
—
|
—
|
—
|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
-20.52 Scores on a scale
Standard Error 1.472
|
-20.95 Scores on a scale
Standard Error 1.547
|
-22.01 Scores on a scale
Standard Error 1.545
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) \[ESR in milimeter/hour (mm/hr)\] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV).
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Global Cohort)
DAS28-CRP
|
-1.28 Scores on a scale
Standard Error 0.064
|
-1.35 Scores on a scale
Standard Error 0.064
|
-2.02 Scores on a scale
Standard Error 0.082
|
-0.71 Scores on a scale
Standard Error 0.085
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 12 (Global Cohort)
DAS28-ESR
|
-1.34 Scores on a scale
Standard Error 0.066
|
-1.40 Scores on a scale
Standard Error 0.066
|
-1.95 Scores on a scale
Standard Error 0.084
|
-0.73 Scores on a scale
Standard Error 0.087
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) \[ESR in milimeter/hour (mm/hr)\] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV).
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
DAS28-ESR, Week 24
|
-1.73 Scores on a scale
Standard Error 0.073
|
-1.79 Scores on a scale
Standard Error 0.074
|
-2.40 Scores on a scale
Standard Error 0.092
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
DAS28-CRP, Week 24
|
-1.65 Scores on a scale
Standard Error 0.070
|
-1.71 Scores on a scale
Standard Error 0.071
|
-2.45 Scores on a scale
Standard Error 0.089
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
DAS28-CRP, Week 52
|
-1.77 Scores on a scale
Standard Error 0.079
|
-1.76 Scores on a scale
Standard Error 0.080
|
-2.40 Scores on a scale
Standard Error 0.098
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
DAS28-ESR, Week 52
|
-1.87 Scores on a scale
Standard Error 0.084
|
-1.82 Scores on a scale
Standard Error 0.084
|
-2.38 Scores on a scale
Standard Error 0.102
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) \[ESR in milimeter/hour (mm/hr)\] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
DAS28-CRP, Week 24
|
-1.76 Scores on a scale
Standard Error 0.139
|
-1.39 Scores on a scale
Standard Error 0.146
|
-1.88 Scores on a scale
Standard Error 0.145
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
DAS28-CRP, Week 52
|
-1.81 Scores on a scale
Standard Error 0.156
|
-1.70 Scores on a scale
Standard Error 0.164
|
-1.97 Scores on a scale
Standard Error 0.165
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
DAS28-ESR, Week 24
|
-1.88 Scores on a scale
Standard Error 0.144
|
-1.48 Scores on a scale
Standard Error 0.149
|
-1.93 Scores on a scale
Standard Error 0.148
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
DAS28-ESR, Week 52
|
-1.88 Scores on a scale
Standard Error 0.165
|
-1.74 Scores on a scale
Standard Error 0.172
|
-1.96 Scores on a scale
Standard Error 0.169
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde mTSS at Week 12 (Global Cohort)
|
0.31 Scores on a scale
Standard Error 0.072
|
0.15 Scores on a scale
Standard Error 0.073
|
0.09 Scores on a scale
Standard Error 0.092
|
0.13 Scores on a scale
Standard Error 0.095
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
0.84 Scores on a scale
Standard Error 0.148
|
0.46 Scores on a scale
Standard Error 0.150
|
0.30 Scores on a scale
Standard Error 0.184
|
—
|
—
|
—
|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
0.42 Scores on a scale
Standard Error 0.092
|
0.32 Scores on a scale
Standard Error 0.094
|
0.15 Scores on a scale
Standard Error 0.115
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
0.18 Scores on a scale
Standard Error 0.185
|
0.51 Scores on a scale
Standard Error 0.196
|
0.21 Scores on a scale
Standard Error 0.196
|
—
|
—
|
—
|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
-0.05 Scores on a scale
Standard Error 0.288
|
0.76 Scores on a scale
Standard Error 0.304
|
0.09 Scores on a scale
Standard Error 0.307
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
-0.38 Scores on a scale
Standard Error 0.033
|
-0.37 Scores on a scale
Standard Error 0.033
|
-0.53 Scores on a scale
Standard Error 0.041
|
—
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
-0.40 Scores on a scale
Standard Error 0.035
|
-0.37 Scores on a scale
Standard Error 0.035
|
-0.52 Scores on a scale
Standard Error 0.043
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
-0.36 Scores on a scale
Standard Error 0.065
|
-0.38 Scores on a scale
Standard Error 0.067
|
-0.33 Scores on a scale
Standard Error 0.067
|
—
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
-0.30 Scores on a scale
Standard Error 0.069
|
-0.37 Scores on a scale
Standard Error 0.070
|
-0.40 Scores on a scale
Standard Error 0.071
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Arthritis Pain VAS at Week 12 (Global Cohort)
|
-18.06 Scores on a scale
Standard Error 1.266
|
-17.13 Scores on a scale
Standard Error 1.256
|
-27.17 Scores on a scale
Standard Error 1.610
|
-10.28 Scores on a scale
Standard Error 1.657
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
-23.32 Scores on a scale
Standard Error 1.351
|
-22.32 Scores on a scale
Standard Error 1.371
|
-31.27 Scores on a scale
Standard Error 1.699
|
—
|
—
|
—
|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
-25.42 Scores on a scale
Standard Error 1.506
|
-25.14 Scores on a scale
Standard Error 1.525
|
-31.49 Scores on a scale
Standard Error 1.846
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
-23.71 Scores on a scale
Standard Error 2.967
|
-21.72 Scores on a scale
Standard Error 3.071
|
-21.62 Scores on a scale
Standard Error 3.082
|
—
|
—
|
—
|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
-23.26 Scores on a scale
Standard Error 2.710
|
-18.45 Scores on a scale
Standard Error 2.793
|
-22.88 Scores on a scale
Standard Error 2.791
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. For the purpose of all analyses up to week12, placebo arms were pooled into single placebo arm to primarily serve as reference for the comparison of active treatment arms. Analysis was performed using multiple imputation method to handle missing data.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Global Cohort)
|
4.29 T-Score
Standard Error 0.363
|
4.48 T-Score
Standard Error 0.361
|
6.58 T-Score
Standard Error 0.464
|
2.05 T-Score
Standard Error 0.478
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. For the purpose of all analyses up to week12, placebo arms were pooled into single placebo arm to primarily serve as reference for the comparison of active treatment arms. Analysis was performed using multiple imputation method to handle missing data.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Mental Component Scores at Week 12 (Global Cohort)
|
2.24 T-Score
Standard Error 0.474
|
2.68 T-Score
Standard Error 0.471
|
3.56 T-Score
Standard Error 0.604
|
2.21 T-Score
Standard Error 0.624
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. For the purpose of all analyses up to week12, placebo arms were pooled into single placebo arm to primarily serve as reference for the comparison of active treatment arms. Only those participants with data available at the indicated time points were analyzed.
Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=506 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=514 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=252 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=244 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Bodily Pain
|
14.82 Scores on a scale
Standard Error 20.264
|
16.13 Scores on a scale
Standard Error 20.997
|
23.75 Scores on a scale
Standard Error 22.916
|
9.21 Scores on a scale
Standard Error 21.040
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
General Health
|
7.48 Scores on a scale
Standard Error 16.025
|
6.74 Scores on a scale
Standard Error 15.582
|
10.48 Scores on a scale
Standard Error 15.647
|
5.16 Scores on a scale
Standard Error 14.863
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Mental Health
|
6.21 Scores on a scale
Standard Error 17.655
|
6.96 Scores on a scale
Standard Error 18.312
|
9.13 Scores on a scale
Standard Error 19.229
|
4.88 Scores on a scale
Standard Error 18.257
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Physical Function
|
12.78 Scores on a scale
Standard Error 19.321
|
14.47 Scores on a scale
Standard Error 21.133
|
18.63 Scores on a scale
Standard Error 20.724
|
8.42 Scores on a scale
Standard Error 20.505
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Role Emotional
|
6.41 Scores on a scale
Standard Error 24.390
|
7.90 Scores on a scale
Standard Error 25.675
|
9.85 Scores on a scale
Standard Error 24.815
|
7.00 Scores on a scale
Standard Error 23.912
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Role Physical
|
12.08 Scores on a scale
Standard Error 21.650
|
12.57 Scores on a scale
Standard Error 22.044
|
17.66 Scores on a scale
Standard Error 21.724
|
9.78 Scores on a scale
Standard Error 20.593
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Social Function
|
8.10 Scores on a scale
Standard Error 23.132
|
9.75 Scores on a scale
Standard Error 25.484
|
14.78 Scores on a scale
Standard Error 25.900
|
6.76 Scores on a scale
Standard Error 23.984
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Global Cohort)
Vitality
|
8.99 Scores on a scale
Standard Error 18.971
|
10.54 Scores on a scale
Standard Error 19.349
|
15.18 Scores on a scale
Standard Error 21.491
|
7.07 Scores on a scale
Standard Error 18.624
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
5.42 T-Score
Standard Error 0.416
|
5.24 T-Score
Standard Error 0.421
|
7.33 T-Score
Standard Error 0.520
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
5.08 T-Score
Standard Error 0.460
|
5.06 T-Score
Standard Error 0.464
|
7.47 T-Score
Standard Error 0.569
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
2.69 T-Score
Standard Error 0.522
|
3.16 T-Score
Standard Error 0.528
|
4.80 T-Score
Standard Error 0.652
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
3.06 T-Score
Standard Error 0.527
|
3.38 T-Score
Standard Error 0.530
|
4.08 T-Score
Standard Error 0.650
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated time points were analyzed.
Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=494 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=486 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=249 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
General Health, Week 24
|
8.80 Scores on a scale
Standard Error 17.357
|
8.18 Scores on a scale
Standard Error 16.569
|
11.82 Scores on a scale
Standard Error 18.258
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
General Health, Week 52
|
8.72 Scores on a scale
Standard Error 17.635
|
8.74 Scores on a scale
Standard Error 17.157
|
12.71 Scores on a scale
Standard Error 18.374
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Mental Health, Week 24
|
7.33 Scores on a scale
Standard Error 18.871
|
7.81 Scores on a scale
Standard Error 19.930
|
11.24 Scores on a scale
Standard Error 19.875
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Mental Health, Week 52
|
8.03 Scores on a scale
Standard Error 18.819
|
8.21 Scores on a scale
Standard Error 19.132
|
9.87 Scores on a scale
Standard Error 19.417
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Physical Function, Week 24
|
16.20 Scores on a scale
Standard Error 21.646
|
16.59 Scores on a scale
Standard Error 22.660
|
21.73 Scores on a scale
Standard Error 23.769
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Physical Function, Week 52
|
16.90 Scores on a scale
Standard Error 21.458
|
17.40 Scores on a scale
Standard Error 23.162
|
22.31 Scores on a scale
Standard Error 26.462
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Role Emotional, Week 24
|
8.33 Scores on a scale
Standard Error 27.318
|
10.01 Scores on a scale
Standard Error 24.860
|
13.45 Scores on a scale
Standard Error 24.656
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Role Emotional, Week 52
|
9.31 Scores on a scale
Standard Error 24.987
|
10.77 Scores on a scale
Standard Error 25.914
|
13.85 Scores on a scale
Standard Error 25.643
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Role Physical, Week 24
|
15.51 Scores on a scale
Standard Error 22.052
|
15.60 Scores on a scale
Standard Error 22.507
|
18.90 Scores on a scale
Standard Error 22.618
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Role Physical, Week 52
|
15.58 Scores on a scale
Standard Error 23.558
|
16.29 Scores on a scale
Standard Error 24.110
|
21.98 Scores on a scale
Standard Error 24.671
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Social Function, Week 24
|
10.25 Scores on a scale
Standard Error 24.377
|
11.34 Scores on a scale
Standard Error 26.893
|
15.91 Scores on a scale
Standard Error 27.581
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Social Function, Week 52
|
11.23 Scores on a scale
Standard Error 24.368
|
12.06 Scores on a scale
Standard Error 26.941
|
14.42 Scores on a scale
Standard Error 27.313
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Vitality, Week 24
|
11.21 Scores on a scale
Standard Error 20.320
|
12.71 Scores on a scale
Standard Error 20.389
|
18.02 Scores on a scale
Standard Error 22.463
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Vitality, Week 52
|
12.96 Scores on a scale
Standard Error 20.197
|
12.58 Scores on a scale
Standard Error 19.150
|
16.35 Scores on a scale
Standard Error 22.327
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Bodily Pain, Week 24
|
18.06 Scores on a scale
Standard Error 21.568
|
18.87 Scores on a scale
Standard Error 23.164
|
26.26 Scores on a scale
Standard Error 24.870
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Bodily Pain, Week 52
|
19.38 Scores on a scale
Standard Error 22.807
|
20.50 Scores on a scale
Standard Error 23.781
|
27.01 Scores on a scale
Standard Error 24.068
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. PCS is primarily derived from 4 domains (PF,role-physical,BP,GH) representing overall physical health. Positive change from baseline, reported using T-score change, indicates improvement in overall physical health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
5.89 T-Score
Standard Error 0.821
|
4.36 T-Score
Standard Error 0.851
|
5.43 T-Score
Standard Error 0.857
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
4.15 T-Score
Standard Error 0.902
|
4.89 T-Score
Standard Error 0.929
|
3.99 T-Score
Standard Error 0.941
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Positive change from baseline, reported using T-score change, indicates improvement in overall mental health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
3.59 T-Score
Standard Error 1.041
|
4.37 T-Score
Standard Error 1.076
|
3.76 T-Score
Standard Error 1.082
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
2.87 T-Score
Standard Error 1.051
|
4.53 T-Score
Standard Error 1.081
|
2.74 T-Score
Standard Error 1.092
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated time points were analyzed.
Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning(PF), bodily pain(BP), role limitations due to physical and emotional problems, general health(GH), mental health(MH), social functioning(SF), vitality. The MCS consists of 4 domains (SF, vitality, MH, role-emotional) and PCS consists of 4 domains (PF, role-physical, BP, GH). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=82 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=76 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=75 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Mental Health, Week 52
|
8.68 Scores on a scale
Standard Error 19.585
|
12.25 Scores on a scale
Standard Error 19.907
|
8.60 Scores on a scale
Standard Error 19.256
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Physical Function, Week 24
|
16.89 Scores on a scale
Standard Error 20.407
|
17.30 Scores on a scale
Standard Error 20.744
|
16.93 Scores on a scale
Standard Error 21.433
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Bodily Pain, Week 24
|
19.61 Scores on a scale
Standard Error 22.430
|
17.93 Scores on a scale
Standard Error 17.710
|
22.73 Scores on a scale
Standard Error 21.012
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Bodily Pain, Week 52
|
18.43 Scores on a scale
Standard Error 23.444
|
19.35 Scores on a scale
Standard Error 19.873
|
20.69 Scores on a scale
Standard Error 23.501
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
General Health, Week 24
|
9.34 Scores on a scale
Standard Error 13.259
|
8.96 Scores on a scale
Standard Error 16.231
|
8.35 Scores on a scale
Standard Error 17.087
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
General Health, Week 52
|
6.16 Scores on a scale
Standard Error 15.885
|
10.52 Scores on a scale
Standard Error 17.755
|
6.69 Scores on a scale
Standard Error 16.707
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Role Emotional, Week 52
|
6.91 Scores on a scale
Standard Error 27.467
|
16.78 Scores on a scale
Standard Error 28.189
|
10.29 Scores on a scale
Standard Error 28.907
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Role Physical, Week 24
|
16.92 Scores on a scale
Standard Error 22.168
|
17.02 Scores on a scale
Standard Error 19.568
|
20.17 Scores on a scale
Standard Error 21.197
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Role Physical, Week 52
|
14.80 Scores on a scale
Standard Error 23.581
|
20.86 Scores on a scale
Standard Error 20.727
|
17.46 Scores on a scale
Standard Error 24.087
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Social Function, Week 24
|
12.80 Scores on a scale
Standard Error 25.381
|
12.17 Scores on a scale
Standard Error 25.247
|
14.33 Scores on a scale
Standard Error 24.634
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Social Function, Week 52
|
8.55 Scores on a scale
Standard Error 29.312
|
16.20 Scores on a scale
Standard Error 25.477
|
15.26 Scores on a scale
Standard Error 24.131
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Vitality, Week 24
|
14.25 Scores on a scale
Standard Error 18.770
|
13.40 Scores on a scale
Standard Error 18.839
|
13.67 Scores on a scale
Standard Error 21.100
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Vitality, Week 52
|
13.32 Scores on a scale
Standard Error 19.826
|
12.50 Scores on a scale
Standard Error 21.417
|
11.31 Scores on a scale
Standard Error 20.581
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Mental Health, Week 24
|
8.72 Scores on a scale
Standard Error 19.623
|
10.20 Scores on a scale
Standard Error 15.842
|
8.87 Scores on a scale
Standard Error 19.270
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Physical Function, Week 52
|
13.55 Scores on a scale
Standard Error 24.025
|
19.72 Scores on a scale
Standard Error 20.769
|
18.53 Scores on a scale
Standard Error 20.608
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Role Emotional, Week 24
|
9.35 Scores on a scale
Standard Error 26.495
|
15.57 Scores on a scale
Standard Error 25.325
|
11.44 Scores on a scale
Standard Error 27.901
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Analysis was performed using multiple imputation method to handle missing data.
The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=270 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Global Cohort)
|
4.76 Scores on a scale
Standard Error 0.482
|
4.91 Scores on a scale
Standard Error 0.479
|
7.92 Scores on a scale
Standard Error 0.615
|
3.68 Scores on a scale
Standard Error 0.637
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Analysis was performed using multiple imputation method to handle missing data.
The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
6.10 Scores on a scale
Standard Error 0.523
|
6.12 Scores on a scale
Standard Error 0.528
|
8.37 Scores on a scale
Standard Error 0.654
|
—
|
—
|
—
|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
6.97 Scores on a scale
Standard Error 0.538
|
6.41 Scores on a scale
Standard Error 0.543
|
8.38 Scores on a scale
Standard Error 0.664
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants in ITT set. Analysis was performed using multiple imputation method to handle missing data.
The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=91 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=90 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
5.73 Scores on a scale
Standard Error 1.061
|
6.50 Scores on a scale
Standard Error 1.096
|
6.01 Scores on a scale
Standard Error 1.105
|
—
|
—
|
—
|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
6.95 Scores on a scale
Standard Error 1.034
|
6.08 Scores on a scale
Standard Error 1.072
|
6.87 Scores on a scale
Standard Error 1.070
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 59Population: The analysis was performed on the Safety Set for Pooled Placebo (collected data till Week 12), GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX (collected data till Week 59).
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=286 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=255 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Global Cohort)
Participants with AE
|
420 Participants
|
408 Participants
|
224 Participants
|
127 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Global Cohort)
Participants with SAE
|
44 Participants
|
43 Participants
|
31 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Global Cohort)
Participants with AESI
|
72 Participants
|
75 Participants
|
32 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=494 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=490 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=267 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=229 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Global Cohort)
Platelets
|
-19.0 Giga cells per liter (10^9/L)
Standard Deviation 50.74
|
-19.9 Giga cells per liter (10^9/L)
Standard Deviation 53.15
|
-34.3 Giga cells per liter (10^9/L)
Standard Deviation 64.33
|
0.8 Giga cells per liter (10^9/L)
Standard Deviation 54.75
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Global Cohort)
Lymphocytes
|
0.002 Giga cells per liter (10^9/L)
Standard Deviation 0.5235
|
-0.019 Giga cells per liter (10^9/L)
Standard Deviation 0.5304
|
0.045 Giga cells per liter (10^9/L)
Standard Deviation 0.5477
|
-0.011 Giga cells per liter (10^9/L)
Standard Deviation 0.4783
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Global Cohort)
Neutrophils
|
-0.444 Giga cells per liter (10^9/L)
Standard Deviation 1.8305
|
-0.647 Giga cells per liter (10^9/L)
Standard Deviation 1.9192
|
-1.054 Giga cells per liter (10^9/L)
Standard Deviation 2.1874
|
0.053 Giga cells per liter (10^9/L)
Standard Deviation 1.9956
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Global Cohort)
Leukocytes
|
-0.45 Giga cells per liter (10^9/L)
Standard Deviation 1.919
|
-0.70 Giga cells per liter (10^9/L)
Standard Deviation 1.992
|
-1.02 Giga cells per liter (10^9/L)
Standard Deviation 2.215
|
0.02 Giga cells per liter (10^9/L)
Standard Deviation 1.984
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=497 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=480 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=255 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Lymphocytes, Week 52
|
0.001 Giga cells per liter (10^9/L)
Standard Deviation 0.5679
|
-0.012 Giga cells per liter (10^9/L)
Standard Deviation 0.5487
|
-0.143 Giga cells per liter (10^9/L)
Standard Deviation 0.5739
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Neutrophils, Week 24
|
-0.508 Giga cells per liter (10^9/L)
Standard Deviation 1.7714
|
-0.647 Giga cells per liter (10^9/L)
Standard Deviation 2.0762
|
-1.135 Giga cells per liter (10^9/L)
Standard Deviation 2.2376
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Leukocytes, Week 24
|
-0.50 Giga cells per liter (10^9/L)
Standard Deviation 1.818
|
-0.66 Giga cells per liter (10^9/L)
Standard Deviation 2.129
|
-1.17 Giga cells per liter (10^9/L)
Standard Deviation 2.269
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Lymphocytes, Week 24
|
0.004 Giga cells per liter (10^9/L)
Standard Deviation 0.5092
|
-0.017 Giga cells per liter (10^9/L)
Standard Deviation 0.5188
|
0.031 Giga cells per liter (10^9/L)
Standard Deviation 0.5294
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Neutrophils, Week 52
|
-0.594 Giga cells per liter (10^9/L)
Standard Deviation 1.8490
|
-0.788 Giga cells per liter (10^9/L)
Standard Deviation 2.1627
|
-1.022 Giga cells per liter (10^9/L)
Standard Deviation 2.4346
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Platelets, Week 24
|
-16.4 Giga cells per liter (10^9/L)
Standard Deviation 61.73
|
-21.0 Giga cells per liter (10^9/L)
Standard Deviation 56.36
|
-32.0 Giga cells per liter (10^9/L)
Standard Deviation 63.74
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Platelets, Week 52
|
-24.9 Giga cells per liter (10^9/L)
Standard Deviation 66.31
|
-22.0 Giga cells per liter (10^9/L)
Standard Deviation 63.94
|
-37.6 Giga cells per liter (10^9/L)
Standard Deviation 70.56
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Leukocytes, Week 52
|
-0.59 Giga cells per liter (10^9/L)
Standard Deviation 1.976
|
-0.80 Giga cells per liter (10^9/L)
Standard Deviation 2.346
|
-1.22 Giga cells per liter (10^9/L)
Standard Deviation 2.465
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=80 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=74 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=64 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Lymphocytes, Week 24
|
-0.072 Giga cells per liter (10^9/L)
Standard Deviation 0.4236
|
0.014 Giga cells per liter (10^9/L)
Standard Deviation 0.5442
|
-0.042 Giga cells per liter (10^9/L)
Standard Deviation 0.5563
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Lymphocytes, Week 52
|
-0.085 Giga cells per liter (10^9/L)
Standard Deviation 0.5077
|
-0.071 Giga cells per liter (10^9/L)
Standard Deviation 0.5098
|
-0.243 Giga cells per liter (10^9/L)
Standard Deviation 0.6030
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Neutrophils, Week 24
|
-0.582 Giga cells per liter (10^9/L)
Standard Deviation 1.6685
|
-0.255 Giga cells per liter (10^9/L)
Standard Deviation 2.1106
|
-0.745 Giga cells per liter (10^9/L)
Standard Deviation 1.9306
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Neutrophils, Week 52
|
-0.605 Giga cells per liter (10^9/L)
Standard Deviation 1.8343
|
-0.288 Giga cells per liter (10^9/L)
Standard Deviation 2.2031
|
-0.617 Giga cells per liter (10^9/L)
Standard Deviation 2.1111
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Platelets, Week 24
|
-11.6 Giga cells per liter (10^9/L)
Standard Deviation 58.77
|
-13.6 Giga cells per liter (10^9/L)
Standard Deviation 40.78
|
-36.1 Giga cells per liter (10^9/L)
Standard Deviation 62.88
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Platelets, Week 52
|
-17.8 Giga cells per liter (10^9/L)
Standard Deviation 39.56
|
-21.1 Giga cells per liter (10^9/L)
Standard Deviation 44.72
|
-27.8 Giga cells per liter (10^9/L)
Standard Deviation 72.75
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Leukocytes, Week 24
|
-0.64 Giga cells per liter (10^9/L)
Standard Deviation 1.669
|
-0.25 Giga cells per liter (10^9/L)
Standard Deviation 2.204
|
-0.84 Giga cells per liter (10^9/L)
Standard Deviation 2.093
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 (Global Cohort)
Leukocytes, Week 52
|
-0.65 Giga cells per liter (10^9/L)
Standard Deviation 2.148
|
-0.38 Giga cells per liter (10^9/L)
Standard Deviation 2.259
|
-0.94 Giga cells per liter (10^9/L)
Standard Deviation 2.134
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters hemoglobin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=492 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=489 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=267 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=231 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Global Cohort)
|
0.8 Grams per liter (g/L)
Standard Deviation 7.50
|
0.1 Grams per liter (g/L)
Standard Deviation 7.57
|
0.4 Grams per liter (g/L)
Standard Deviation 8.53
|
-1.0 Grams per liter (g/L)
Standard Deviation 7.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters hemoglobin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=497 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=479 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=255 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
0.5 Grams per liter (g/L)
Standard Deviation 8.89
|
1.0 Grams per liter (g/L)
Standard Deviation 8.57
|
1.9 Grams per liter (g/L)
Standard Deviation 9.23
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
0.6 Grams per liter (g/L)
Standard Deviation 10.83
|
0.0 Grams per liter (g/L)
Standard Deviation 10.12
|
1.0 Grams per liter (g/L)
Standard Deviation 10.35
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters hemoglobin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=79 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=74 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=64 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
1.2 Grams per liter (g/L)
Standard Deviation 6.36
|
1.2 Grams per liter (g/L)
Standard Deviation 6.10
|
3.2 Grams per liter (g/L)
Standard Deviation 9.01
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
0.8 Grams per liter (g/L)
Standard Deviation 7.96
|
1.8 Grams per liter (g/L)
Standard Deviation 8.99
|
2.1 Grams per liter (g/L)
Standard Deviation 10.14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) and gamma-glutamyl transferase (GGT) levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=511 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=504 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=273 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=231 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Global Cohort)
GGT
|
-1.5 International units per liter (IU/L)
Standard Deviation 20.77
|
0.3 International units per liter (IU/L)
Standard Deviation 44.60
|
-1.1 International units per liter (IU/L)
Standard Deviation 17.60
|
-1.7 International units per liter (IU/L)
Standard Deviation 25.38
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Global Cohort)
AP
|
-1.3 International units per liter (IU/L)
Standard Deviation 19.79
|
0.4 International units per liter (IU/L)
Standard Deviation 28.71
|
-5.1 International units per liter (IU/L)
Standard Deviation 19.95
|
-1.6 International units per liter (IU/L)
Standard Deviation 22.96
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Global Cohort)
ALT
|
0.8 International units per liter (IU/L)
Standard Deviation 14.14
|
1.2 International units per liter (IU/L)
Standard Deviation 13.49
|
3.0 International units per liter (IU/L)
Standard Deviation 15.73
|
0.3 International units per liter (IU/L)
Standard Deviation 15.88
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Global Cohort)
AST
|
1.3 International units per liter (IU/L)
Standard Deviation 8.34
|
2.0 International units per liter (IU/L)
Standard Deviation 11.35
|
3.8 International units per liter (IU/L)
Standard Deviation 12.23
|
-0.1 International units per liter (IU/L)
Standard Deviation 8.73
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=497 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=480 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=257 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
ALT, Week 52
|
-0.1 International units per liter (IU/L)
Standard Deviation 14.16
|
2.0 International units per liter (IU/L)
Standard Deviation 16.35
|
3.7 International units per liter (IU/L)
Standard Deviation 15.33
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
GGT, Week 24
|
-1.2 International units per liter (IU/L)
Standard Deviation 25.56
|
0.5 International units per liter (IU/L)
Standard Deviation 32.53
|
-1.6 International units per liter (IU/L)
Standard Deviation 16.76
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
AP, Week 24
|
-0.3 International units per liter (IU/L)
Standard Deviation 23.40
|
0.6 International units per liter (IU/L)
Standard Deviation 20.47
|
-7.9 International units per liter (IU/L)
Standard Deviation 24.03
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
AP, Week 52
|
0.3 International units per liter (IU/L)
Standard Deviation 20.20
|
1.4 International units per liter (IU/L)
Standard Deviation 22.40
|
-5.1 International units per liter (IU/L)
Standard Deviation 23.34
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
ALT, Week 24
|
1.0 International units per liter (IU/L)
Standard Deviation 18.23
|
4.6 International units per liter (IU/L)
Standard Deviation 63.38
|
4.1 International units per liter (IU/L)
Standard Deviation 21.70
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
AST, Week 24
|
1.2 International units per liter (IU/L)
Standard Deviation 9.71
|
3.8 International units per liter (IU/L)
Standard Deviation 45.20
|
4.2 International units per liter (IU/L)
Standard Deviation 13.20
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
AST, Week 52
|
1.0 International units per liter (IU/L)
Standard Deviation 8.08
|
2.0 International units per liter (IU/L)
Standard Deviation 11.47
|
3.9 International units per liter (IU/L)
Standard Deviation 11.17
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
GGT, Week 52
|
-1.0 International units per liter (IU/L)
Standard Deviation 24.25
|
0.2 International units per liter (IU/L)
Standard Deviation 22.40
|
-0.1 International units per liter (IU/L)
Standard Deviation 17.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=83 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=74 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=64 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
AP, Week 24
|
-0.3 International units per liter (IU/L)
Standard Deviation 15.77
|
-3.5 International units per liter (IU/L)
Standard Deviation 19.93
|
-2.8 International units per liter (IU/L)
Standard Deviation 23.41
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
AP, Week 52
|
-2.8 International units per liter (IU/L)
Standard Deviation 19.07
|
-1.6 International units per liter (IU/L)
Standard Deviation 27.58
|
-2.7 International units per liter (IU/L)
Standard Deviation 26.76
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
ALT, Week 24
|
-0.2 International units per liter (IU/L)
Standard Deviation 14.86
|
0.2 International units per liter (IU/L)
Standard Deviation 14.15
|
6.4 International units per liter (IU/L)
Standard Deviation 15.92
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
ALT, Week 52
|
1.0 International units per liter (IU/L)
Standard Deviation 20.01
|
0.7 International units per liter (IU/L)
Standard Deviation 13.66
|
7.8 International units per liter (IU/L)
Standard Deviation 24.01
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
AST, Week 24
|
-0.2 International units per liter (IU/L)
Standard Deviation 10.16
|
1.4 International units per liter (IU/L)
Standard Deviation 6.42
|
5.0 International units per liter (IU/L)
Standard Deviation 9.96
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
AST, Week 52
|
1.3 International units per liter (IU/L)
Standard Deviation 14.54
|
2.2 International units per liter (IU/L)
Standard Deviation 7.07
|
7.0 International units per liter (IU/L)
Standard Deviation 16.92
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
GGT, Week 24
|
0.8 International units per liter (IU/L)
Standard Deviation 20.15
|
-2.0 International units per liter (IU/L)
Standard Deviation 18.05
|
0.0 International units per liter (IU/L)
Standard Deviation 25.57
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
GGT, Week 52
|
-2.1 International units per liter (IU/L)
Standard Deviation 15.84
|
-1.1 International units per liter (IU/L)
Standard Deviation 16.29
|
0.8 International units per liter (IU/L)
Standard Deviation 23.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=506 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=499 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=271 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=231 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Global Cohort)
|
0.3 Micromoles per liter (umol/L)
Standard Deviation 2.84
|
0.5 Micromoles per liter (umol/L)
Standard Deviation 2.68
|
0.5 Micromoles per liter (umol/L)
Standard Deviation 3.11
|
0.2 Micromoles per liter (umol/L)
Standard Deviation 2.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=496 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=477 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=256 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
0.5 Micromoles per liter (umol/L)
Standard Deviation 2.66
|
0.5 Micromoles per liter (umol/L)
Standard Deviation 2.78
|
0.6 Micromoles per liter (umol/L)
Standard Deviation 2.73
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
0.3 Micromoles per liter (umol/L)
Standard Deviation 2.66
|
0.6 Micromoles per liter (umol/L)
Standard Deviation 2.80
|
0.9 Micromoles per liter (umol/L)
Standard Deviation 2.83
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=81 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=73 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=64 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
-0.1 Micromoles per liter (umol/L)
Standard Deviation 2.88
|
0.6 Micromoles per liter (umol/L)
Standard Deviation 2.44
|
0.4 Micromoles per liter (umol/L)
Standard Deviation 2.20
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
0.3 Micromoles per liter (umol/L)
Standard Deviation 3.07
|
0.3 Micromoles per liter (umol/L)
Standard Deviation 2.06
|
0.4 Micromoles per liter (umol/L)
Standard Deviation 2.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter albumin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=511 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=504 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=273 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=231 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Global Cohort)
|
0.1 Grams per liter (g/L)
Standard Deviation 2.56
|
0.1 Grams per liter (g/L)
Standard Deviation 2.49
|
1.1 Grams per liter (g/L)
Standard Deviation 2.60
|
-0.3 Grams per liter (g/L)
Standard Deviation 2.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter albumin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=497 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=479 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=257 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 24
|
0.2 Grams per liter (g/L)
Standard Deviation 2.72
|
0.3 Grams per liter (g/L)
Standard Deviation 2.59
|
1.6 Grams per liter (g/L)
Standard Deviation 2.95
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
Week 52
|
0.3 Grams per liter (g/L)
Standard Deviation 2.77
|
0.3 Grams per liter (g/L)
Standard Deviation 2.88
|
1.3 Grams per liter (g/L)
Standard Deviation 3.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter albumin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=83 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=74 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=64 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 52
|
-0.0 Grams per liter (g/L)
Standard Deviation 2.87
|
0.9 Grams per liter (g/L)
Standard Deviation 2.64
|
2.1 Grams per liter (g/L)
Standard Deviation 3.22
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Global Cohort)
Week 24
|
0.1 Grams per liter (g/L)
Standard Deviation 2.33
|
0.6 Grams per liter (g/L)
Standard Deviation 2.13
|
2.5 Grams per liter (g/L)
Standard Deviation 2.99
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 4 and not Week 12 as no data collected. Week 4 is not pre-specified time point to report.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 12) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=438 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=437 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=226 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
|
0.121 Millimoles per liter (mmol/L)
Standard Deviation 0.8198
|
0.129 Millimoles per liter (mmol/L)
Standard Deviation 0.8076
|
0.402 Millimoles per liter (mmol/L)
Standard Deviation 0.8794
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 4) and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=71 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=66 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=55 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)
|
0.198 Millimoles per liter (mmol/L)
Standard Deviation 0.9586
|
0.255 Millimoles per liter (mmol/L)
Standard Deviation 0.8086
|
0.691 Millimoles per liter (mmol/L)
Standard Deviation 0.9233
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 4 and not Week 12 as no data collected. Week 4 is not pre-specified time point to report.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 12) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=438 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=437 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=226 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
HDL Cholesterol, Direct
|
0.026 Millimoles per liter (mmol/L)
Standard Deviation 0.2415
|
0.010 Millimoles per liter (mmol/L)
Standard Deviation 0.2812
|
0.157 Millimoles per liter (mmol/L)
Standard Deviation 0.3184
|
—
|
—
|
—
|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
LDL Cholesterol
|
0.076 Millimoles per liter (mmol/L)
Standard Deviation 0.6971
|
0.093 Millimoles per liter (mmol/L)
Standard Deviation 0.6396
|
0.191 Millimoles per liter (mmol/L)
Standard Deviation 0.7423
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 4) and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=71 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=66 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=55 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)
LDL Cholesterol
|
0.188 Millimoles per liter (mmol/L)
Standard Deviation 0.7796
|
0.184 Millimoles per liter (mmol/L)
Standard Deviation 0.6039
|
0.495 Millimoles per liter (mmol/L)
Standard Deviation 0.7375
|
—
|
—
|
—
|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Global Cohort)
HDL Cholesterol, Direct
|
-0.041 Millimoles per liter (mmol/L)
Standard Deviation 0.2841
|
0.045 Millimoles per liter (mmol/L)
Standard Deviation 0.2769
|
0.135 Millimoles per liter (mmol/L)
Standard Deviation 0.3094
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 4 and not Week 12 as no data collected. Week 4 is not pre-specified time point to report.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 12) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis. Only those participants with data available at the specified data points were analyzed.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=438 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=437 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=226 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Global Cohort)
|
0.045 Millimoles per liter (mmol/L)
Standard Deviation 0.5902
|
0.054 Millimoles per liter (mmol/L)
Standard Deviation 0.5970
|
0.117 Millimoles per liter (mmol/L)
Standard Deviation 0.6444
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 4) and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
TBlood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=71 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=66 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=55 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Global Cohort)
|
0.111 Millimoles per liter (mmol/L)
Standard Deviation 0.4371
|
0.034 Millimoles per liter (mmol/L)
Standard Deviation 0.5246
|
0.129 Millimoles per liter (mmol/L)
Standard Deviation 0.5816
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 59Population: The analysis was performed on the Safety Set for Pooled Placebo (collected data till Week 12), GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX (collected data till Week 59).
Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=286 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=255 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Hypertriglyceridemia, Total, Grade 3
|
10 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Aspartate aminotransferase increased, Total, Grade 4
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Neutrophil count decreased, Total, Grade 4
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Alanine aminotransferase increased,Total,Grade 3
|
4 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Aspartate aminotransferase increased,Total,Grade 3
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Anemia, Total, Grade 3
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Lymphocyte count decreased, Grade 3
|
9 Participants
|
11 Participants
|
9 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Neutrophil count decreased, Total, Grade 3
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Lymphocyte count decreased, Grade 4
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Alanine aminotransferase increased, Total, Grade 4
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Creatinine increased, Total, Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Chronic Kidney Disease, Total, Grade 3
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Chronic Kidney Disease, Total, Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Hemoglobin increased, Total, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
White blood cell decreased, Total, Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Global Cohort)
Hypertriglyceridemia, Total, Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At baselinePopulation: The analysis was performed on the Safety Set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis.
Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=286 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=91 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
n=75 Participants
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Global Cohort)
|
201.587 Microgram per liter (ug/L)
Standard Deviation 519.9638
|
193.911 Microgram per liter (ug/L)
Standard Deviation 402.0018
|
189.505 Microgram per liter (ug/L)
Standard Deviation 344.7866
|
217.622 Microgram per liter (ug/L)
Standard Deviation 399.6172
|
267.669 Microgram per liter (ug/L)
Standard Deviation 642.5823
|
252.209 Microgram per liter (ug/L)
Standard Deviation 671.7397
|
SECONDARY outcome
Timeframe: Up to Week 52Population: The analysis was performed on the Safety set. Fifteen participants in Placebo group received active treatment of Tofacitinib mistakenly from Week 4 instead of Week 12 as planned. They were added with the Tofacitinib arm in safety analysis.
Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=286 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=91 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
n=89 Participants
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
n=75 Participants
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-GSK3196165 Antibodies (Global Cohort)
|
6 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT-Supplementary Asia Cohort Population consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Less Than or Equal to (<=)10 [CDAI Low Disease Activity (LDA)] at Week 12 (Asia Cohort)
|
13.0 Percentage of participants
|
12.0 Percentage of participants
|
58.0 Percentage of participants
|
19.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: ITT-Supplementary Asia Cohort Population consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=46 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Asia Cohort)
|
-0.22 Scores on a scale
Standard Deviation 0.479
|
-0.25 Scores on a scale
Standard Deviation 0.537
|
-0.47 Scores on a scale
Standard Deviation 0.281
|
0.02 Scores on a scale
Standard Deviation 0.577
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
21.0 Percentage of participants
|
19.0 Percentage of participants
|
53.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
45.0 Percentage of participants
|
41.0 Percentage of participants
|
47.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
33.0 Percentage of participants
|
33.0 Percentage of participants
|
43.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=10 (CDAI LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
75.0 Percentage of participants
|
67.0 Percentage of participants
|
40.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 12 (Asia Cohort)
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
11.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
0.0 Percentage of participants
|
7.0 Percentage of participants
|
24.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
6.0 Percentage of participants
|
16.0 Percentage of participants
|
13.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving CDAI Total Score <=2.8 (CDAI Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
20.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
ACR50/70 is calculated as a 50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)\]. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=44 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Asia Cohort)
ACR50
|
11.0 Percentage of participants
|
12.0 Percentage of participants
|
53.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving 50%/70% Improvement in American College of Rheumatology Criteria(ACR50/70) at Week 12 (Asia Cohort)
ACR70
|
5.0 Percentage of participants
|
2.0 Percentage of participants
|
16.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20%/50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)\]. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=37 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ACR50, Week 24
|
19.0 Percentage of participants
|
24.0 Percentage of participants
|
53.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ACR20, Week 24
|
54.0 Percentage of participants
|
55.0 Percentage of participants
|
19.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ACR20, Week 52
|
63.0 Percentage of participants
|
77.0 Percentage of participants
|
87.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ACR50, Week 52
|
37.0 Percentage of participants
|
48.0 Percentage of participants
|
53.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ACR70, Week 24
|
8.0 Percentage of participants
|
7.0 Percentage of participants
|
29.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ACR70, Week 52
|
13.0 Percentage of participants
|
10.0 Percentage of participants
|
27.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
ACR20/50/70 is calculated as a 20%/50%/70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50%/70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) \[VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)\]. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ACR20, Week 24
|
33.0 Percentage of participants
|
17.0 Percentage of participants
|
38.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ACR20, Week 52
|
75.0 Percentage of participants
|
33.0 Percentage of participants
|
67.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ACR50, Week 52
|
50.0 Percentage of participants
|
17.0 Percentage of participants
|
67.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ACR50, Week 24
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
43.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ACR70, Week 24
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
14.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving ACR20/50/70 at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ACR70, Week 52
|
50.0 Percentage of participants
|
17.0 Percentage of participants
|
17.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 (Asia Cohort)
|
16.0 Percentage of participants
|
21.0 Percentage of participants
|
58.0 Percentage of participants
|
10.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 (Asia Cohort)
|
20.0 Percentage of participants
|
9.0 Percentage of participants
|
47.0 Percentage of participants
|
10.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
24.0 Percentage of participants
|
21.0 Percentage of participants
|
53.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
39.0 Percentage of participants
|
34.0 Percentage of participants
|
67.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
16.0 Percentage of participants
|
16.0 Percentage of participants
|
47.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
25.0 Percentage of participants
|
20.0 Percentage of participants
|
47.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
33.0 Percentage of participants
|
33.0 Percentage of participants
|
43.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
75.0 Percentage of participants
|
50.0 Percentage of participants
|
67.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR\<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
33.0 Percentage of participants
|
0.0 Percentage of participants
|
29.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
50.0 Percentage of participants
|
0.0 Percentage of participants
|
17.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (\<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 (Asia Cohort)
|
11.0 Percentage of participants
|
5.0 Percentage of participants
|
42.0 Percentage of participants
|
10.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 12 (Asia Cohort)
|
2.0 Percentage of participants
|
2.0 Percentage of participants
|
21.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (\<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
13.0 Percentage of participants
|
19.0 Percentage of participants
|
41.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
19.0 Percentage of participants
|
25.0 Percentage of participants
|
53.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
8.0 Percentage of participants
|
12.0 Percentage of participants
|
29.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
7.0 Percentage of participants
|
17.0 Percentage of participants
|
20.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP less than (\<)2.6. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
33.0 Percentage of participants
|
0.0 Percentage of participants
|
29.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
50.0 Percentage of participants
|
17.0 Percentage of participants
|
17.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving DAS28 ESR <2.6 (DAS28-ESR Remission) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
25.0 Percentage of participants
|
0.0 Percentage of participants
|
17.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. Only those participants with data available at the indicated timepoints were analyzed. For the purpose of all analyses up to week 12, placebo arms were pooled into single placebo arm to primarily serve as reference for comparison of active treatment arms.
DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; DAS28\<=3.2 and DAS28 decrease from Baseline (\>1.2: good response),(\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response); DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline (\>1.2: moderate response),(\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response) and DAS28\>5.1 and DAS28 decrease from Baseline (\>1.2: moderate response),(\>0.6 to \<=1.2: no response) and (\<=0.6: no response).If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=44 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=41 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12(Asia Cohort)
|
66.0 Percentage of participants
|
61.0 Percentage of participants
|
84.0 Percentage of participants
|
33.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 \<=3.2 and DAS28 decrease from Baseline (\>1.2: good response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response); if current DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response) and if current DAS28 \>5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: no response) and (\<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=37 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
70.0 Percentage of participants
|
84.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
65.0 Percentage of participants
|
64.0 Percentage of participants
|
94.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
DAS28-CRP and DAS28-ESR scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 \<=3.2 and DAS28 decrease from Baseline (\>1.2: good response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response); if current DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response) and if current DAS28 \>5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: no response) and (\<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
50.0 Percentage of participants
|
50.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving a Good/Moderate EULAR Response at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. Only those participants with data available at the indicated timepoints were analyzed.
Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving ACR/EULAR Remission at Week 12 (Asia Cohort)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Achieving ACR/EULAR Remission at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of \<=0.5. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=9 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=3 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=2 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving no Radiographic Progression Van Der Heijde Modified Total Sharp Scores (mTSS) <= 0.5) at Week 12 (Asia Cohort)
|
67.0 Percentage of participants
|
67.0 Percentage of participants
|
67.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of \<=0.5. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=2 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
83.0 Percentage of participants
|
60.0 Percentage of participants
|
50.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
40.0 Percentage of participants
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. No radiographic progression is defined as a change from Baseline in van der Heijde mTSS score of \<=0.5. Percentage values are rounded off.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=1 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=1 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving no Radiographic Progression (mTSS <= 0.5) at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (PtGA and PhGA VAS with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=44 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CDAI Total Score at Week 12 (Asia Cohort)
|
-13.75 Scores on a scale
Standard Deviation 10.935
|
-10.91 Scores on a scale
Standard Deviation 11.649
|
-19.47 Scores on a scale
Standard Deviation 12.718
|
-4.38 Scores on a scale
Standard Deviation 8.640
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=37 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
-15.27 Scores on a scale
Standard Deviation 12.329
|
-13.39 Scores on a scale
Standard Deviation 10.575
|
-21.44 Scores on a scale
Standard Deviation 11.208
|
—
|
—
|
—
|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
-18.29 Scores on a scale
Standard Deviation 13.199
|
-19.35 Scores on a scale
Standard Deviation 13.923
|
-23.21 Scores on a scale
Standard Deviation 12.303
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Baseline was defined as the latest pre-dose assessment with a non-missing value (NMV), including those from unscheduled visits. Change from Baseline (CB) was calculated by subtracting the post dose (PD) visit value from the Baseline value (BV). For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
-8.78 Scores on a scale
Standard Deviation 6.086
|
-12.28 Scores on a scale
Standard Deviation 10.842
|
-20.47 Scores on a scale
Standard Deviation 12.133
|
—
|
—
|
—
|
|
Change From Baseline in CDAI Total Score at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
-16.28 Scores on a scale
Standard Deviation 5.351
|
-17.47 Scores on a scale
Standard Deviation 11.166
|
-23.18 Scores on a scale
Standard Deviation 13.070
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) \[ESR in milimeter/hour (mm/hr)\] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=44 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 (Asia Cohort)
DAS28-CRP
|
-1.26 Scores on a scale
Standard Deviation 1.034
|
-1.05 Scores on a scale
Standard Deviation 0.968
|
-2.27 Scores on a scale
Standard Deviation 1.089
|
-0.47 Scores on a scale
Standard Deviation 0.950
|
—
|
—
|
|
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 (Asia Cohort)
DAS28-ESR
|
-1.33 Scores on a scale
Standard Deviation 1.023
|
-1.11 Scores on a scale
Standard Deviation 0.964
|
-2.15 Scores on a scale
Standard Deviation 1.161
|
-0.40 Scores on a scale
Standard Deviation 0.937
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) \[ESR in milimeter/hour (mm/hr)\] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=37 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
DAS28-CRP, Week 24
|
-1.41 Scores on a scale
Standard Deviation 1.221
|
-1.28 Scores on a scale
Standard Deviation 1.086
|
-2.29 Scores on a scale
Standard Deviation 1.037
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
DAS28-CRP, Week 52
|
-1.63 Scores on a scale
Standard Deviation 1.353
|
-1.82 Scores on a scale
Standard Deviation 1.262
|
-2.47 Scores on a scale
Standard Deviation 1.253
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
DAS28-ESR, Week 24
|
-1.50 Scores on a scale
Standard Deviation 1.153
|
-1.27 Scores on a scale
Standard Deviation 1.121
|
-2.30 Scores on a scale
Standard Deviation 1.246
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
DAS28-ESR, Week 52
|
-1.76 Scores on a scale
Standard Deviation 1.358
|
-1.84 Scores on a scale
Standard Deviation 1.303
|
-2.42 Scores on a scale
Standard Deviation 1.318
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR) \[ESR in milimeter/hour (mm/hr)\] and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
DAS28-ESR, Week 52
|
-1.82 Scores on a scale
Standard Deviation 1.183
|
-1.46 Scores on a scale
Standard Deviation 0.912
|
-2.48 Scores on a scale
Standard Deviation 1.186
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
DAS28-CRP, Week 24
|
-1.27 Scores on a scale
Standard Deviation 1.171
|
-1.08 Scores on a scale
Standard Deviation 0.852
|
-2.14 Scores on a scale
Standard Deviation 1.242
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
DAS28-CRP, Week 52
|
-2.24 Scores on a scale
Standard Deviation 1.200
|
-1.52 Scores on a scale
Standard Deviation 1.005
|
-2.63 Scores on a scale
Standard Deviation 1.244
|
—
|
—
|
—
|
|
Change From Baseline in DAS28-CRP/DAS28-ESR at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
DAS28-ESR, Week 24
|
-0.91 Scores on a scale
Standard Deviation 1.216
|
-0.99 Scores on a scale
Standard Deviation 0.897
|
-2.06 Scores on a scale
Standard Deviation 1.053
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=9 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=3 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=2 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde mTSS at Week 12 (Asia Cohort)
|
1.22 Scores on a scale
Standard Deviation 2.476
|
3.42 Scores on a scale
Standard Deviation 7.889
|
0.33 Scores on a scale
Standard Deviation 0.577
|
0.25 Scores on a scale
Standard Deviation 0.354
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=2 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
1.40 Scores on a scale
Standard Deviation 1.673
|
0.00 Scores on a scale
Standard Deviation 0.000
|
0.50 Scores on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
-0.08 Scores on a scale
Standard Deviation 0.665
|
5.60 Scores on a scale
Standard Deviation 10.922
|
0.50 Scores on a scale
Standard Deviation 0.707
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score range from 0 to 448 for mTSS with higher values representing higher disease activity. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=1 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=1 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
0.50 Scores on a scale
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
0.00 Scores on a scale
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Van Der Heijde mTSS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
0.50 Scores on a scale
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
0.00 Scores on a scale
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
HAQ-Disability Index, Week 52
|
-0.36 Scores on a scale
Standard Deviation 0.573
|
-0.40 Scores on a scale
Standard Deviation 0.604
|
-0.59 Scores on a scale
Standard Deviation 0.483
|
—
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
HAQ-Disability Index, Week 24
|
-0.25 Scores on a scale
Standard Deviation 0.569
|
-0.29 Scores on a scale
Standard Deviation 0.524
|
-0.48 Scores on a scale
Standard Deviation 0.266
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
HAQ-DI is a 20-question instrument that assesses the degree of difficulty of a participant in accomplishing tasks in eight functional areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Overall HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
HAQ-Disability Index, Week 24
|
-0.33 Scores on a scale
Standard Deviation 0.921
|
-0.02 Scores on a scale
Standard Deviation 0.436
|
-0.46 Scores on a scale
Standard Deviation 0.431
|
—
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
HAQ-Disability Index, Week 52
|
-0.19 Scores on a scale
Standard Deviation 1.139
|
-0.19 Scores on a scale
Standard Deviation 0.438
|
-0.52 Scores on a scale
Standard Deviation 0.442
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=46 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Arthritis Pain VAS at Week 12 (Asia Cohort)
|
-20.0 Scores on a scale
Standard Deviation 22.57
|
-18.0 Scores on a scale
Standard Deviation 25.37
|
-21.2 Scores on a scale
Standard Deviation 22.91
|
-1.8 Scores on a scale
Standard Deviation 21.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
-24.4 Scores on a scale
Standard Deviation 22.90
|
-25.2 Scores on a scale
Standard Deviation 25.71
|
-32.9 Scores on a scale
Standard Deviation 25.97
|
—
|
—
|
—
|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
-30.4 Scores on a scale
Standard Deviation 26.98
|
-27.9 Scores on a scale
Standard Deviation 23.51
|
-33.0 Scores on a scale
Standard Deviation 23.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
-14.2 Scores on a scale
Standard Deviation 20.71
|
-13.5 Scores on a scale
Standard Deviation 27.57
|
-27.0 Scores on a scale
Standard Deviation 21.86
|
—
|
—
|
—
|
|
Change From Baseline in Arthritis Pain VAS at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
-32.3 Scores on a scale
Standard Deviation 14.45
|
-21.8 Scores on a scale
Standard Deviation 34.17
|
-34.4 Scores on a scale
Standard Deviation 27.50
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. Only those participants with data available at the indicated timepoints were analyzed. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form (SF)-36 Physical Component Scores at Week 12 (Asia Cohort)
|
4.051 T-Score
Standard Deviation 6.1927
|
3.040 T-Score
Standard Deviation 5.8359
|
8.312 T-Score
Standard Deviation 6.6143
|
0.222 T-Score
Standard Deviation 4.5222
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. Only those participants with data available at the indicated timepoints were analyzed. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring.Baseline=latest pre-dose assessment with NMV, including those from unscheduled visits.CB=subtracting PD visit value from BV.For purpose of all analyses up to week12, placebo arms were pooled into single arm to primarily serve as reference for comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Mental Component Scores at Week 12 (Asia Cohort)
|
1.529 T-Score
Standard Deviation 9.2379
|
2.197 T-Score
Standard Deviation 8.4871
|
1.149 T-Score
Standard Deviation 7.6184
|
0.392 T-Score
Standard Deviation 7.0528
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. Only those participants with data available at the indicated timepoints were analyzed. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Mental Health
|
4.00 Scores on a scale
Standard Deviation 17.340
|
1.43 Scores on a scale
Standard Deviation 14.579
|
1.32 Scores on a scale
Standard Deviation 14.419
|
0.24 Scores on a scale
Standard Deviation 13.179
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Vitality
|
7.22 Scores on a scale
Standard Deviation 20.684
|
8.48 Scores on a scale
Standard Deviation 15.849
|
9.54 Scores on a scale
Standard Deviation 20.023
|
2.08 Scores on a scale
Standard Deviation 11.238
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Bodily Pain
|
12.64 Scores on a scale
Standard Deviation 13.888
|
7.93 Scores on a scale
Standard Deviation 14.984
|
23.42 Scores on a scale
Standard Deviation 22.741
|
1.62 Scores on a scale
Standard Deviation 18.712
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
General Health
|
6.33 Scores on a scale
Standard Deviation 17.092
|
2.86 Scores on a scale
Standard Deviation 13.448
|
9.16 Scores on a scale
Standard Deviation 15.174
|
-4.05 Scores on a scale
Standard Deviation 14.928
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Physical Function
|
8.67 Scores on a scale
Standard Deviation 15.537
|
8.10 Scores on a scale
Standard Deviation 17.355
|
14.74 Scores on a scale
Standard Deviation 19.037
|
1.90 Scores on a scale
Standard Deviation 18.740
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Role Emotional
|
5.93 Scores on a scale
Standard Deviation 20.150
|
7.54 Scores on a scale
Standard Deviation 23.268
|
7.89 Scores on a scale
Standard Deviation 21.957
|
2.38 Scores on a scale
Standard Deviation 25.020
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Role Physical
|
8.89 Scores on a scale
Standard Deviation 16.722
|
8.33 Scores on a scale
Standard Deviation 23.494
|
20.07 Scores on a scale
Standard Deviation 30.730
|
2.98 Scores on a scale
Standard Deviation 19.924
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 12 (Asia Cohort)
Social Function
|
3.06 Scores on a scale
Standard Deviation 20.670
|
8.63 Scores on a scale
Standard Deviation 20.379
|
13.82 Scores on a scale
Standard Deviation 19.937
|
0.00 Scores on a scale
Standard Deviation 16.298
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health.Positive change from baseline, reported using T-score change, indicates improvement in overall physical health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=37 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
4.220 T-Score
Standard Deviation 7.5564
|
3.362 T-Score
Standard Deviation 5.9357
|
7.826 T-Score
Standard Deviation 9.0545
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
4.646 T-Score
Standard Deviation 6.7378
|
5.328 T-Score
Standard Deviation 5.8824
|
9.942 T-Score
Standard Deviation 5.7938
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health.Positive change from baseline, reported using T-score change, indicates improvement in overall mental health.Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=37 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
3.837 T-Score
Standard Deviation 9.6474
|
0.918 T-Score
Standard Deviation 10.3466
|
1.923 T-Score
Standard Deviation 9.4063
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
-0.157 T-Score
Standard Deviation 8.7537
|
2.741 T-Score
Standard Deviation 6.6865
|
0.071 T-Score
Standard Deviation 8.0170
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=37 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Mental Health, Week 52
|
7.42 Scores on a scale
Standard Deviation 18.343
|
1.29 Scores on a scale
Standard Deviation 17.510
|
6.00 Scores on a scale
Standard Deviation 17.341
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Role Emotional, Week 24
|
1.58 Scores on a scale
Standard Deviation 22.209
|
8.53 Scores on a scale
Standard Deviation 19.259
|
9.80 Scores on a scale
Standard Deviation 25.215
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Social Function, Week 52
|
10.48 Scores on a scale
Standard Deviation 20.941
|
5.24 Scores on a scale
Standard Deviation 22.770
|
11.67 Scores on a scale
Standard Deviation 28.530
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Bodily Pain, Week 24
|
13.43 Scores on a scale
Standard Deviation 18.292
|
8.88 Scores on a scale
Standard Deviation 13.862
|
30.59 Scores on a scale
Standard Deviation 25.048
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Bodily Pain, Week 52
|
16.77 Scores on a scale
Standard Deviation 17.333
|
16.97 Scores on a scale
Standard Deviation 16.956
|
30.20 Scores on a scale
Standard Deviation 23.035
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
General Health, Week 24
|
4.97 Scores on a scale
Standard Deviation 19.591
|
4.19 Scores on a scale
Standard Deviation 14.101
|
2.41 Scores on a scale
Standard Deviation 12.037
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
General Health, Week 52
|
5.74 Scores on a scale
Standard Deviation 17.216
|
4.13 Scores on a scale
Standard Deviation 14.509
|
10.87 Scores on a scale
Standard Deviation 13.958
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Mental Health, Week 24
|
0.68 Scores on a scale
Standard Deviation 18.226
|
4.17 Scores on a scale
Standard Deviation 13.521
|
2.65 Scores on a scale
Standard Deviation 9.701
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Physical Function, Week 24
|
6.08 Scores on a scale
Standard Deviation 18.264
|
10.60 Scores on a scale
Standard Deviation 17.916
|
14.71 Scores on a scale
Standard Deviation 20.269
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Physical Function, Week 52
|
10.00 Scores on a scale
Standard Deviation 17.512
|
11.29 Scores on a scale
Standard Deviation 17.367
|
21.67 Scores on a scale
Standard Deviation 17.491
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Role Emotional, Week 52
|
9.41 Scores on a scale
Standard Deviation 20.609
|
8.87 Scores on a scale
Standard Deviation 23.267
|
11.11 Scores on a scale
Standard Deviation 21.973
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Role Physical, Week 24
|
8.45 Scores on a scale
Standard Deviation 24.572
|
8.63 Scores on a scale
Standard Deviation 20.332
|
18.01 Scores on a scale
Standard Deviation 40.437
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Role Physical, Week 52
|
13.31 Scores on a scale
Standard Deviation 18.381
|
12.90 Scores on a scale
Standard Deviation 23.768
|
21.67 Scores on a scale
Standard Deviation 30.969
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Social Function, Week 24
|
2.70 Scores on a scale
Standard Deviation 18.194
|
8.63 Scores on a scale
Standard Deviation 16.904
|
3.68 Scores on a scale
Standard Deviation 37.699
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Vitality, Week 24
|
5.07 Scores on a scale
Standard Deviation 22.040
|
8.04 Scores on a scale
Standard Deviation 15.937
|
4.78 Scores on a scale
Standard Deviation 25.342
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Vitality, Week 52
|
11.49 Scores on a scale
Standard Deviation 22.308
|
6.05 Scores on a scale
Standard Deviation 21.377
|
11.25 Scores on a scale
Standard Deviation 23.170
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. PCS is primarily derived from 4 domains (PF,role-physical,BP,GH) representing overall physical health. Positive change from baseline, reported using T-score change, indicates improvement in overall physical health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
3.818 T-Score
Standard Deviation 3.4904
|
3.268 T-Score
Standard Deviation 4.8182
|
7.024 T-Score
Standard Deviation 6.0185
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Physical Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
1.762 T-Score
Standard Deviation 5.8183
|
1.675 T-Score
Standard Deviation 6.9009
|
5.544 T-Score
Standard Deviation 5.4800
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality. Each of 8 domains is scored using average, 0-100; higher score represents better health. MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Positive change from baseline, reported using T-score change, indicates improvement in overall mental health. Quality Metric software was used for scoring. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
-0.028 T-Score
Standard Deviation 9.4600
|
-1.940 T-Score
Standard Deviation 8.3373
|
2.401 T-Score
Standard Deviation 6.1426
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Mental Component Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
3.158 T-Score
Standard Deviation 8.1659
|
3.950 T-Score
Standard Deviation 5.3971
|
4.889 T-Score
Standard Deviation 8.1905
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning(PF), bodily pain(BP), role limitations due to physical and emotional problems, general health(GH), mental health(MH), social functioning(SF), vitality. The MCS consists of 4 domains (SF, vitality, MH, role-emotional) and PCS consists of 4 domains (PF, role-physical, BP, GH). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. Quality Metric software was used for scoring for SF-36. Baseline was defined as latest pre-dose assessment with non-missing value, including from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Bodily Pain, Week 24
|
18.83 Scores on a scale
Standard Deviation 23.017
|
12.17 Scores on a scale
Standard Deviation 26.180
|
18.00 Scores on a scale
Standard Deviation 23.951
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
General Health, Week 24
|
-3.83 Scores on a scale
Standard Deviation 14.689
|
0.83 Scores on a scale
Standard Deviation 16.558
|
-1.29 Scores on a scale
Standard Deviation 12.148
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Physical Function, Week 52
|
2.51 Scores on a scale
Standard Deviation 18.925
|
5.83 Scores on a scale
Standard Deviation 10.205
|
21.43 Scores on a scale
Standard Deviation 15.738
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Role Physical, Week 52
|
9.38 Scores on a scale
Standard Deviation 14.878
|
1.04 Scores on a scale
Standard Deviation 14.479
|
16.96 Scores on a scale
Standard Deviation 25.697
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Vitality, Week 52
|
4.69 Scores on a scale
Standard Deviation 23.593
|
8.33 Scores on a scale
Standard Deviation 6.455
|
8.93 Scores on a scale
Standard Deviation 14.815
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Bodily Pain, Week 52
|
13.50 Scores on a scale
Standard Deviation 26.889
|
12.83 Scores on a scale
Standard Deviation 37.280
|
23.00 Scores on a scale
Standard Deviation 20.905
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
General Health, Week 52
|
5.00 Scores on a scale
Standard Deviation 14.697
|
-0.83 Scores on a scale
Standard Deviation 13.934
|
0.57 Scores on a scale
Standard Deviation 18.911
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Mental Health, Week 24
|
9.17 Scores on a scale
Standard Deviation 13.197
|
5.83 Scores on a scale
Standard Deviation 12.813
|
14.29 Scores on a scale
Standard Deviation 5.345
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Mental Health, Week 52
|
1.25 Scores on a scale
Standard Deviation 13.769
|
-2.50 Scores on a scale
Standard Deviation 16.355
|
6.43 Scores on a scale
Standard Deviation 7.480
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Physical Function, Week 24
|
0.01 Scores on a scale
Standard Deviation 17.887
|
2.50 Scores on a scale
Standard Deviation 15.732
|
25.71 Scores on a scale
Standard Deviation 18.356
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Role Emotional, Week 24
|
11.11 Scores on a scale
Standard Deviation 24.532
|
9.72 Scores on a scale
Standard Deviation 16.171
|
15.48 Scores on a scale
Standard Deviation 40.379
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Role Emotional, Week 52
|
0.00 Scores on a scale
Standard Deviation 11.785
|
-2.78 Scores on a scale
Standard Deviation 21.515
|
11.91 Scores on a scale
Standard Deviation 27.154
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Role Physical, Week 24
|
13.54 Scores on a scale
Standard Deviation 15.520
|
7.29 Scores on a scale
Standard Deviation 10.013
|
15.18 Scores on a scale
Standard Deviation 21.907
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Social Function, Week 24
|
-2.08 Scores on a scale
Standard Deviation 20.026
|
4.17 Scores on a scale
Standard Deviation 6.455
|
3.57 Scores on a scale
Standard Deviation 17.252
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Social Function, Week 52
|
3.13 Scores on a scale
Standard Deviation 31.250
|
-6.25 Scores on a scale
Standard Deviation 15.309
|
10.71 Scores on a scale
Standard Deviation 18.298
|
—
|
—
|
—
|
|
Change From Baseline in SF-36 Domain Scores at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Vitality, Week 24
|
3.13 Scores on a scale
Standard Deviation 11.693
|
11.46 Scores on a scale
Standard Deviation 14.479
|
15.18 Scores on a scale
Standard Deviation 8.733
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the ITT-Supplementary Asia Cohort Population, which consisted of participants randomized on or after 07-August-2021 who received at least one dose of study treatment. This population was based on the treatment the participant was randomized to. Only those participants with data available at the indicated timepoints were analyzed.
The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=46 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 (Asia Cohort)
|
2.4 Scores on a scale
Standard Deviation 8.01
|
4.0 Scores on a scale
Standard Deviation 6.58
|
6.4 Scores on a scale
Standard Deviation 7.64
|
0.3 Scores on a scale
Standard Deviation 9.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=42 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
1.9 Scores on a scale
Standard Deviation 9.22
|
4.7 Scores on a scale
Standard Deviation 5.96
|
5.1 Scores on a scale
Standard Deviation 10.18
|
—
|
—
|
—
|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
3.3 Scores on a scale
Standard Deviation 8.91
|
5.3 Scores on a scale
Standard Deviation 7.65
|
7.7 Scores on a scale
Standard Deviation 8.91
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Only those participants with data available at the indicated timepoints were analyzed.
The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For efficacy assessments baseline is interpreted as Day 1.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
4.0 Scores on a scale
Standard Deviation 6.16
|
2.2 Scores on a scale
Standard Deviation 1.94
|
2.0 Scores on a scale
Standard Deviation 7.94
|
—
|
—
|
—
|
|
Change From Baseline in FACIT-Fatigue at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
6.3 Scores on a scale
Standard Deviation 5.16
|
1.3 Scores on a scale
Standard Deviation 4.93
|
3.0 Scores on a scale
Standard Deviation 10.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 59Population: The analysis was performed on the Safety Set for Pooled Placebo (collected data till Week 12), GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX (collected data till Week 59).
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=47 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=49 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=23 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Asia Cohort)
SAE
|
5 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Asia Cohort)
AESI
|
4 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (Asia Cohort)
AE
|
37 Participants
|
43 Participants
|
18 Participants
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Asia Cohort)
WBC count
|
-0.48 Giga cells per liter (10^9/L)
Standard Deviation 1.369
|
-0.35 Giga cells per liter (10^9/L)
Standard Deviation 1.699
|
-1.25 Giga cells per liter (10^9/L)
Standard Deviation 1.038
|
-0.18 Giga cells per liter (10^9/L)
Standard Deviation 1.518
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Asia Cohort)
Platelet count
|
-17.8 Giga cells per liter (10^9/L)
Standard Deviation 51.99
|
-20.4 Giga cells per liter (10^9/L)
Standard Deviation 44.57
|
-22.9 Giga cells per liter (10^9/L)
Standard Deviation 50.17
|
5.7 Giga cells per liter (10^9/L)
Standard Deviation 48.47
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Asia Cohort)
Lymphocytes
|
0.094 Giga cells per liter (10^9/L)
Standard Deviation 0.3241
|
0.069 Giga cells per liter (10^9/L)
Standard Deviation 0.3391
|
0.070 Giga cells per liter (10^9/L)
Standard Deviation 0.3942
|
0.117 Giga cells per liter (10^9/L)
Standard Deviation 0.4069
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of White Blood Cell (WBC) Count, Platelet Count, Neutrophils, Lymphocytes at Week 12 (Giga Cells Per Liter) (Asia Cohort)
Neutrophils
|
-0.654 Giga cells per liter (10^9/L)
Standard Deviation 1.3274
|
-0.473 Giga cells per liter (10^9/L)
Standard Deviation 1.5847
|
-1.316 Giga cells per liter (10^9/L)
Standard Deviation 1.0213
|
-0.352 Giga cells per liter (10^9/L)
Standard Deviation 1.2533
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
WBC count, Week 24
|
-0.42 Giga cells per liter (10^9/L)
Standard Deviation 1.780
|
-0.56 Giga cells per liter (10^9/L)
Standard Deviation 1.467
|
-0.26 Giga cells per liter (10^9/L)
Standard Deviation 3.492
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
WBC count, Week 52
|
-0.60 Giga cells per liter (10^9/L)
Standard Deviation 1.538
|
-0.50 Giga cells per liter (10^9/L)
Standard Deviation 1.338
|
-1.30 Giga cells per liter (10^9/L)
Standard Deviation 1.207
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Platelet count, Week 24
|
-24.8 Giga cells per liter (10^9/L)
Standard Deviation 61.57
|
-8.0 Giga cells per liter (10^9/L)
Standard Deviation 39.63
|
-3.2 Giga cells per liter (10^9/L)
Standard Deviation 74.58
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Neutrophils, Week 24
|
-0.632 Giga cells per liter (10^9/L)
Standard Deviation 1.7911
|
-0.737 Giga cells per liter (10^9/L)
Standard Deviation 1.3842
|
-0.829 Giga cells per liter (10^9/L)
Standard Deviation 1.7091
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Neutrophils, Week 52
|
-0.794 Giga cells per liter (10^9/L)
Standard Deviation 1.6493
|
-0.475 Giga cells per liter (10^9/L)
Standard Deviation 1.1881
|
-0.828 Giga cells per liter (10^9/L)
Standard Deviation 1.2338
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Lymphocytes, Week 52
|
0.129 Giga cells per liter (10^9/L)
Standard Deviation 0.3706
|
-0.002 Giga cells per liter (10^9/L)
Standard Deviation 0.2894
|
-0.414 Giga cells per liter (10^9/L)
Standard Deviation 0.3126
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Platelet count, Week 52
|
-27.4 Giga cells per liter (10^9/L)
Standard Deviation 54.86
|
-24.5 Giga cells per liter (10^9/L)
Standard Deviation 53.19
|
-28.6 Giga cells per liter (10^9/L)
Standard Deviation 51.39
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Lymphocytes, Week 24
|
0.107 Giga cells per liter (10^9/L)
Standard Deviation 0.3436
|
0.114 Giga cells per liter (10^9/L)
Standard Deviation 0.2605
|
0.454 Giga cells per liter (10^9/L)
Standard Deviation 1.7675
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of change from baseline in hematology parameters including WBC count, platelet count, neutrophils, lymphocytes. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
WBC count, Week 24
|
-0.10 Giga cells per liter (10^9/L)
Standard Deviation 1.404
|
-1.10 Giga cells per liter (10^9/L)
Standard Deviation 0.729
|
-0.53 Giga cells per liter (10^9/L)
Standard Deviation 1.559
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Platelet count, Week 24
|
-33.5 Giga cells per liter (10^9/L)
Standard Deviation 39.29
|
1.2 Giga cells per liter (10^9/L)
Standard Deviation 45.66
|
-54.4 Giga cells per liter (10^9/L)
Standard Deviation 72.52
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Platelet count, Week 52
|
-33.8 Giga cells per liter (10^9/L)
Standard Deviation 48.88
|
-27.4 Giga cells per liter (10^9/L)
Standard Deviation 49.23
|
-62.7 Giga cells per liter (10^9/L)
Standard Deviation 67.67
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Lymphocytes, Week 24
|
-0.160 Giga cells per liter (10^9/L)
Standard Deviation 0.2929
|
0.185 Giga cells per liter (10^9/L)
Standard Deviation 0.3747
|
0.030 Giga cells per liter (10^9/L)
Standard Deviation 0.4946
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
WBC count, Week 52
|
-0.28 Giga cells per liter (10^9/L)
Standard Deviation 0.544
|
-0.08 Giga cells per liter (10^9/L)
Standard Deviation 1.057
|
0.85 Giga cells per liter (10^9/L)
Standard Deviation 1.285
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Neutrophils, Week 24
|
0.042 Giga cells per liter (10^9/L)
Standard Deviation 1.1970
|
-1.153 Giga cells per liter (10^9/L)
Standard Deviation 0.8378
|
-0.599 Giga cells per liter (10^9/L)
Standard Deviation 1.6470
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Neutrophils, Week 52
|
-0.205 Giga cells per liter (10^9/L)
Standard Deviation 0.3770
|
-0.040 Giga cells per liter (10^9/L)
Standard Deviation 0.6118
|
1.305 Giga cells per liter (10^9/L)
Standard Deviation 1.0918
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of WBC Count, Platelet Count, Neutrophils, Lymphocytes at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Lymphocytes, Week 52
|
0.093 Giga cells per liter (10^9/L)
Standard Deviation 0.1962
|
0.092 Giga cells per liter (10^9/L)
Standard Deviation 0.3667
|
-0.568 Giga cells per liter (10^9/L)
Standard Deviation 0.5136
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Only those participants with data available at the specified data points were analyzed.
Blood samples was collected for the assessment of hematology parameters. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=45 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 12 (Asia Cohort)
|
2.3 Grams per liter (g/L)
Standard Deviation 8.44
|
0.0 Grams per liter (g/L)
Standard Deviation 8.45
|
1.4 Grams per liter (g/L)
Standard Deviation 5.70
|
-1.7 Grams per liter (g/L)
Standard Deviation 7.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the specified data points were analyzed.
Blood samples was collected for the assessment of hematology parameters. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
3.2 Grams per liter (g/L)
Standard Deviation 10.72
|
-0.8 Grams per liter (g/L)
Standard Deviation 9.81
|
2.4 Grams per liter (g/L)
Standard Deviation 8.97
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
1.9 Grams per liter (g/L)
Standard Deviation 10.65
|
-1.8 Grams per liter (g/L)
Standard Deviation 9.95
|
2.4 Grams per liter (g/L)
Standard Deviation 9.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples was collected for the assessment of hematology parameters. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
-0.5 Grams per liter (g/L)
Standard Deviation 7.94
|
-1.2 Grams per liter (g/L)
Standard Deviation 8.77
|
3.3 Grams per liter (g/L)
Standard Deviation 4.68
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
-0.5 Grams per liter (g/L)
Standard Deviation 6.35
|
-1.0 Grams per liter (g/L)
Standard Deviation 11.51
|
2.5 Grams per liter (g/L)
Standard Deviation 7.23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) and gamma-glutamyl transferase (GGT) levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=46 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Asia Cohort)
Aspartate Aminotransferase
|
3.5 International units per liter (IU/L)
Standard Deviation 13.14
|
2.0 International units per liter (IU/L)
Standard Deviation 5.29
|
2.9 International units per liter (IU/L)
Standard Deviation 4.82
|
0.8 International units per liter (IU/L)
Standard Deviation 8.26
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Asia Cohort)
Alanine Aminotransferase
|
2.1 International units per liter (IU/L)
Standard Deviation 16.90
|
2.5 International units per liter (IU/L)
Standard Deviation 7.49
|
0.0 International units per liter (IU/L)
Standard Deviation 7.85
|
2.8 International units per liter (IU/L)
Standard Deviation 16.44
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Asia Cohort)
Alkaline Phosphatase
|
-1.9 International units per liter (IU/L)
Standard Deviation 14.73
|
-1.0 International units per liter (IU/L)
Standard Deviation 11.52
|
-4.2 International units per liter (IU/L)
Standard Deviation 15.44
|
-0.6 International units per liter (IU/L)
Standard Deviation 16.52
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma-Glutamyl Transpeptidase (GGT) at Week 12 (Asia Cohort)
Gamma-Glutamyl Transpeptidase
|
-3.0 International units per liter (IU/L)
Standard Deviation 10.95
|
0.7 International units per liter (IU/L)
Standard Deviation 12.28
|
-3.5 International units per liter (IU/L)
Standard Deviation 14.69
|
2.6 International units per liter (IU/L)
Standard Deviation 12.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
AST. Week 24
|
0.1 International units per liter (IU/L)
Standard Deviation 10.02
|
2.1 International units per liter (IU/L)
Standard Deviation 6.20
|
3.2 International units per liter (IU/L)
Standard Deviation 7.27
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
AST. Week 52
|
0.9 International units per liter (IU/L)
Standard Deviation 8.65
|
1.2 International units per liter (IU/L)
Standard Deviation 5.34
|
4.2 International units per liter (IU/L)
Standard Deviation 10.58
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ALT, Week 24
|
-1.0 International units per liter (IU/L)
Standard Deviation 16.19
|
2.5 International units per liter (IU/L)
Standard Deviation 8.56
|
-0.2 International units per liter (IU/L)
Standard Deviation 14.22
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
ALT, Week 52
|
-2.3 International units per liter (IU/L)
Standard Deviation 15.36
|
-0.4 International units per liter (IU/L)
Standard Deviation 5.95
|
2.0 International units per liter (IU/L)
Standard Deviation 19.78
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
AP, Week 24
|
-0.3 International units per liter (IU/L)
Standard Deviation 15.15
|
0.3 International units per liter (IU/L)
Standard Deviation 16.64
|
-5.6 International units per liter (IU/L)
Standard Deviation 15.14
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
AP, Week 52
|
-5.7 International units per liter (IU/L)
Standard Deviation 15.00
|
-6.3 International units per liter (IU/L)
Standard Deviation 18.37
|
-5.1 International units per liter (IU/L)
Standard Deviation 21.76
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
GGT, Week 24
|
-4.4 International units per liter (IU/L)
Standard Deviation 9.83
|
0.7 International units per liter (IU/L)
Standard Deviation 16.68
|
-5.0 International units per liter (IU/L)
Standard Deviation 17.60
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
GGT, Week 52
|
-6.8 International units per liter (IU/L)
Standard Deviation 10.38
|
-2.1 International units per liter (IU/L)
Standard Deviation 12.53
|
1.4 International units per liter (IU/L)
Standard Deviation 20.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP and GGT levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
AST, Week 24
|
-0.5 International units per liter (IU/L)
Standard Deviation 2.43
|
-4.0 International units per liter (IU/L)
Standard Deviation 9.14
|
4.3 International units per liter (IU/L)
Standard Deviation 4.07
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
AST, Week 52
|
1.3 International units per liter (IU/L)
Standard Deviation 2.36
|
-1.2 International units per liter (IU/L)
Standard Deviation 1.64
|
2.6 International units per liter (IU/L)
Standard Deviation 5.41
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ALT, Week 24
|
0.5 International units per liter (IU/L)
Standard Deviation 2.43
|
-14.0 International units per liter (IU/L)
Standard Deviation 25.91
|
1.7 International units per liter (IU/L)
Standard Deviation 7.36
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
ALT, Week 52
|
6.0 International units per liter (IU/L)
Standard Deviation 6.98
|
-4.0 International units per liter (IU/L)
Standard Deviation 5.92
|
-2.0 International units per liter (IU/L)
Standard Deviation 8.75
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
AP, Week 24
|
-0.3 International units per liter (IU/L)
Standard Deviation 7.74
|
-6.0 International units per liter (IU/L)
Standard Deviation 12.57
|
0.0 International units per liter (IU/L)
Standard Deviation 26.44
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
AP, Week 52
|
-10.5 International units per liter (IU/L)
Standard Deviation 18.16
|
1.6 International units per liter (IU/L)
Standard Deviation 4.98
|
-13.6 International units per liter (IU/L)
Standard Deviation 21.48
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
GGT, Week 24
|
-1.3 International units per liter (IU/L)
Standard Deviation 5.75
|
-10.8 International units per liter (IU/L)
Standard Deviation 23.23
|
-6.0 International units per liter (IU/L)
Standard Deviation 12.94
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of AST, ALT, AP, GGT at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
GGT, Week 52
|
3.0 International units per liter (IU/L)
Standard Deviation 6.78
|
-4.0 International units per liter (IU/L)
Standard Deviation 12.53
|
-7.6 International units per liter (IU/L)
Standard Deviation 15.45
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=46 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 12 (Asia Cohort)
|
0.2 Micromoles per liter (umol/L)
Standard Deviation 2.32
|
0.1 Micromoles per liter (umol/L)
Standard Deviation 2.64
|
1.1 Micromoles per liter (umol/L)
Standard Deviation 4.71
|
-0.1 Micromoles per liter (umol/L)
Standard Deviation 2.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
0.3 Micromoles per liter (umol/L)
Standard Deviation 2.60
|
0.2 Micromoles per liter (umol/L)
Standard Deviation 2.82
|
0.3 Micromoles per liter (umol/L)
Standard Deviation 3.79
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
0.7 Micromoles per liter (umol/L)
Standard Deviation 2.69
|
1.6 Micromoles per liter (umol/L)
Standard Deviation 4.75
|
1.6 Micromoles per liter (umol/L)
Standard Deviation 2.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of clinical chemistry parameter total bilirubin level. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
-0.7 Micromoles per liter (umol/L)
Standard Deviation 1.97
|
3.2 Micromoles per liter (umol/L)
Standard Deviation 3.54
|
0.3 Micromoles per liter (umol/L)
Standard Deviation 2.75
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
0.0 Micromoles per liter (umol/L)
Standard Deviation 1.41
|
2.0 Micromoles per liter (umol/L)
Standard Deviation 2.00
|
0.0 Micromoles per liter (umol/L)
Standard Deviation 1.41
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: The analysis was performed on the Safety Set. Only those participants with data available at the specified data points were analyzed.
Blood samples was collected for the assessment of clinical chemistry parameter albumin. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=46 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=21 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 12 (Asia Cohort)
|
0.8 Grams per liter (g/L)
Standard Deviation 2.99
|
-0.2 Grams per liter (g/L)
Standard Deviation 2.26
|
2.1 Grams per liter (g/L)
Standard Deviation 2.51
|
-0.5 Grams per liter (g/L)
Standard Deviation 2.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24 and Week 52Population: The analysis was performed on Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Blood samples was collected for the assessment of clinical chemistry parameter albumin. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=38 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=43 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=17 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 24
|
0.7 Grams per liter (g/L)
Standard Deviation 2.81
|
0.3 Grams per liter (g/L)
Standard Deviation 2.90
|
1.4 Grams per liter (g/L)
Standard Deviation 4.01
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
Week 52
|
1.0 Grams per liter (g/L)
Standard Deviation 2.54
|
0.2 Grams per liter (g/L)
Standard Deviation 2.47
|
2.6 Grams per liter (g/L)
Standard Deviation 3.50
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 12), Week 24 and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples was collected for the assessment of clinical chemistry parameter albumin. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting post dose visit value from Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=7 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 24
|
0.3 Grams per liter (g/L)
Standard Deviation 3.01
|
1.2 Grams per liter (g/L)
Standard Deviation 1.83
|
2.1 Grams per liter (g/L)
Standard Deviation 2.54
|
—
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameter of Albumin at Week 24 and Week 52 for Placebo Switched Arms (Asia Cohort)
Week 52
|
0.3 Grams per liter (g/L)
Standard Deviation 1.71
|
2.0 Grams per liter (g/L)
Standard Deviation 1.58
|
3.8 Grams per liter (g/L)
Standard Deviation 3.70
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 4 and not Week 12 as no data collected. Week 4 is not pre-specified time point to report.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 12) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on the Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=29 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=29 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=16 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
|
-0.166 Millimoles per liter (mmol/L)
Standard Deviation 0.8128
|
0.146 Millimoles per liter (mmol/L)
Standard Deviation 0.5227
|
0.743 Millimoles per liter (mmol/L)
Standard Deviation 0.7569
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 4) and Week 52Population: The analysis was performed on Safety Set-Placebo switch. Only those participants with data available at the indicated timepoints were analyzed.
Blood samples were collected for the assessment of lipid profile of total cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=4 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Total Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)
|
0.085 Millimoles per liter (mmol/L)
Standard Deviation 0.4905
|
0.318 Millimoles per liter (mmol/L)
Standard Deviation 1.4969
|
0.816 Millimoles per liter (mmol/L)
Standard Deviation 0.5924
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 4 and not Week 12 as no data collected. Week 4 is not pre-specified time point to report.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 12) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on the Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=29 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=29 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=16 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
LDL cholesterol
|
-0.258 Millimoles per liter (mmol/L)
Standard Deviation 0.7697
|
0.076 Millimoles per liter (mmol/L)
Standard Deviation 0.4614
|
0.334 Millimoles per liter (mmol/L)
Standard Deviation 0.4170
|
—
|
—
|
—
|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
HDL cholesterol
|
-0.044 Millimoles per liter (mmol/L)
Standard Deviation 0.2490
|
-0.012 Millimoles per liter (mmol/L)
Standard Deviation 0.2779
|
0.146 Millimoles per liter (mmol/L)
Standard Deviation 0.3082
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 4) and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the assessment of fasting lipid profile including LDL cholesterol, HDL cholesterol levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=4 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)
LDL cholesterol
|
0.218 Millimoles per liter (mmol/L)
Standard Deviation 0.5604
|
0.094 Millimoles per liter (mmol/L)
Standard Deviation 1.2936
|
0.438 Millimoles per liter (mmol/L)
Standard Deviation 0.4544
|
—
|
—
|
—
|
|
Change From Baseline in Lipid Profile Parameter of LDL Cholesterol, HDL Cholesterol at Week 52 for Placebo Switched Arms (Asia Cohort)
HDL cholesterol
|
0.000 Millimoles per liter (mmol/L)
Standard Deviation 0.1089
|
0.042 Millimoles per liter (mmol/L)
Standard Deviation 0.2400
|
0.226 Millimoles per liter (mmol/L)
Standard Deviation 0.2204
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 4 and not Week 12 as no data collected. Week 4 is not pre-specified time point to report.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 12) and Week 24Population: Blood samples were collected at indicated time points per schedule of assessment in protocol. Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 24 was a secondary objective, however for lipid panel, there is no corresponding time point in schedule of assessment. Consequently, the objective that can be assessed for the lipid panel is Week 16 and not Week 24 as no data collected. Week 16 is not pre-specified time point to report.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For safety assessments baseline is interpreted as Week 12.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 52Population: The analysis was performed on the Safety Set participants who received study intervention from Day 01 to Week 52. Only those participants with data available at the indicated timepoints were analyzed.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=29 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=29 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=16 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Treatment Arms Who Started Study Intervention From Day 1 (Asia Cohort)
|
0.443 Millimoles per liter (mmol/L)
Standard Deviation 1.4807
|
0.180 Millimoles per liter (mmol/L)
Standard Deviation 0.4439
|
0.345 Millimoles per liter (mmol/L)
Standard Deviation 0.6262
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 4) and Week 52Population: The analysis was performed on the Safety Set-Placebo switch. Only those participants with data available at the specified data points were analyzed.
Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value. For lipid profile assessments, baseline is interpreted as Week 4.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=4 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=5 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Lipid Profile Parameter of Triglycerides at Week 52 for Placebo Switched Arms (Asia Cohort)
|
-0.288 Millimoles per liter (mmol/L)
Standard Deviation 0.7348
|
0.398 Millimoles per liter (mmol/L)
Standard Deviation 0.6266
|
0.328 Millimoles per liter (mmol/L)
Standard Deviation 0.5965
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 59Population: The analysis was performed on the Safety Set for Pooled Placebo (collected data till Week 12), GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX (collected data till Week 59).
Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=47 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=49 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=23 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Asia Cohort)
Cholesterol - high, Total, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Asia Cohort)
Lymphocyte count decreased, Total, Grade 3
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities (Asia Cohort)
Hypertriglyceridemia, Total, Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At baselinePopulation: The analysis was performed on the Safety Set. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=1 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody (Asia Cohort)
|
526.0 Microgram per liter (ug/L)
Standard Deviation NA
NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 59Population: The analysis was performed on the pharmacokinetic population which included participants in the Safety population who had at least 1 non-missing pharmacokinetic assessment.
Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=47 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=49 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=19 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=6 Participants
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
n=8 Participants
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
n=9 Participants
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-GSK3196165 Antibodies (Asia Cohort)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12 to Week 59Population: The analysis was performed on Safety Set-Placebo switch for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX (collected data from Week 12 to 59).
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=85 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=80 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=67 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Global Cohort)
Participants with AE
|
54 Participants
|
52 Participants
|
45 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Global Cohort)
Participants with SAE
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Global Cohort)
Participants with AESI
|
6 Participants
|
12 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 to Week 59Population: The analysis was performed on Safety Set-Placebo switch for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX (collected data from Week 12 to 59).
Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=85 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=80 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=67 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort)
Anemia, Total, Grade 3
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort)
Lymphocyte count decreased, Grade 3
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort)
Neutrophil count decreased, Total, Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort)
Lymphocyte count decreased, Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Global Cohort)
Hypertriglyceridemia, Total, Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 to Week 59Population: The analysis was performed on Safety Set-Placebo switch for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX (collected data from Week 12 to 59).
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=8 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=8 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Asia Cohort)
Participants with SAE
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Asia Cohort)
Participants with AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) for Placebo Switched Arms (Asia Cohort)
Participants with AE
|
6 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 to Week 59Population: The analysis was performed on Safety Set-Placebo switch for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX (collected data from Week 12 to 59).
Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.
Outcome measures
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=6 Participants
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=8 Participants
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=8 Participants
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Asia Cohort)
Cholesterol - high, Total, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Asia Cohort)
Lymphocyte count decreased, Total, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities for Placebo Switched Arms (Asia Cohort)
Hypertriglyceridemia, Total, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
GSK3196165 90mg + csDMARD (Global Cohort)
Serious events: 44 serious events
Other events: 233 other events
Deaths: 5 deaths
GSK3196165 150mg + csDMARD (Global Cohort)
Serious events: 43 serious events
Other events: 208 other events
Deaths: 6 deaths
Tofacitinib 5mg + csDMARD (Global Cohort)
Serious events: 31 serious events
Other events: 105 other events
Deaths: 2 deaths
Pooled Placebo (Global Cohort)
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)
Serious events: 5 serious events
Other events: 28 other events
Deaths: 1 deaths
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
Serious events: 3 serious events
Other events: 31 other events
Deaths: 1 deaths
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
GSK3196165 90mg + csDMARD (Asia Cohort)
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
GSK3196165 150mg + csDMARD (Asia Cohort)
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Tofacitinib 5mg + csDMARD (Asia Cohort)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Pooled Placebo (Asia Cohort)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 participants at risk
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 participants at risk
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=286 participants at risk
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=255 participants at risk
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)
n=85 participants at risk
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
n=80 participants at risk
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
n=67 participants at risk
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
GSK3196165 90mg + csDMARD (Asia Cohort)
n=47 participants at risk
Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
GSK3196165 150mg + csDMARD (Asia Cohort)
n=49 participants at risk
Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Asia Cohort)
n=19 participants at risk
Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Asia Cohort)
n=23 participants at risk
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)
n=6 participants at risk
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)
n=8 participants at risk
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)
n=8 participants at risk
Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/85 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
2/545 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/80 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Eye disorders
Glaucoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Eye disorders
Ulcerative keratitis
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/85 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.5%
1/67 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Mesenteric cyst
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
General disorders
Death
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
General disorders
Fatigue
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
General disorders
Pyrexia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
General disorders
Sudden death
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
2/545 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Immune system disorders
Secondary amyloidosis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.37%
2/539 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
COVID-19
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.37%
2/539 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.92%
5/545 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.93%
5/539 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.4%
7/286 • Number of events 7 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.5%
1/67 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pneumonia
|
0.37%
2/545 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.70%
2/286 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/80 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pneumonia bacterial
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/85 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pyelonephritis
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Sepsis
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Septic shock
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.39%
1/255 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.39%
1/255 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Transaminases increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.39%
1/255 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.73%
4/545 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.74%
4/539 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.39%
1/255 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/80 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.37%
2/539 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.4%
2/85 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.39%
1/255 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.39%
1/255 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.37%
2/539 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/80 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
1/23 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Facial paralysis
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Seizure
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Syncope
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.35%
1/286 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/85 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Product Issues
Device dislocation
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.18%
1/545 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/85 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural cyst
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/80 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.37%
2/539 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/85 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.19%
1/539 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage II
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
Other adverse events
| Measure |
GSK3196165 90mg + csDMARD (Global Cohort)
n=545 participants at risk
Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).
|
GSK3196165 150mg + csDMARD (Global Cohort)
n=539 participants at risk
Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Global Cohort)
n=286 participants at risk
Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Global Cohort)
n=255 participants at risk
Participants received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)
n=85 participants at risk
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Global Cohort)
n=80 participants at risk
Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Global Cohort)
n=67 participants at risk
Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
GSK3196165 90mg + csDMARD (Asia Cohort)
n=47 participants at risk
Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
GSK3196165 150mg + csDMARD (Asia Cohort)
n=49 participants at risk
Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.
|
Tofacitinib 5mg + csDMARD (Asia Cohort)
n=19 participants at risk
Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks
|
Pooled Placebo (Asia Cohort)
n=23 participants at risk
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD until Week 12. The placebo arms are pooled into a single placebo arm.
|
Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)
n=6 participants at risk
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)
n=8 participants at risk
Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks
|
Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)
n=8 participants at risk
Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
35/545 • Number of events 41 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
3.5%
19/539 • Number of events 20 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.8%
8/286 • Number of events 9 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/85 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.0%
4/80 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
3.0%
2/67 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.5%
4/47 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
14.3%
7/49 • Number of events 8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
1/23 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.1%
3/49 • Number of events 8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.1%
33/545 • Number of events 45 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
7.1%
38/539 • Number of events 57 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.4%
24/286 • Number of events 32 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
9.4%
8/85 • Number of events 9 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
3.8%
3/80 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.0%
4/67 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.2%
5/49 • Number of events 12 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Eye disorders
Scleritis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
2/47 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.1%
2/49 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.4%
3/47 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.7%
2/23 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
General disorders
Application site rash
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
General disorders
Injection site reaction
|
7.7%
42/545 • Number of events 112 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.7%
47/539 • Number of events 137 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.7%
5/286 • Number of events 7 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
3/255 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.9%
5/85 • Number of events 8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
10/80 • Number of events 15 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
2/47 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.2%
5/49 • Number of events 6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
General disorders
Vaccination site pain
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.1%
3/49 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.1%
3/49 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
COVID-19
|
9.0%
49/545 • Number of events 51 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.9%
32/539 • Number of events 35 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
9.4%
27/286 • Number of events 27 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
3.5%
3/85 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.0%
4/80 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
11.9%
8/67 • Number of events 8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
2/47 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.2%
5/49 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.1%
2/49 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.1%
2/49 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Influenza
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
28/545 • Number of events 33 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.1%
33/539 • Number of events 43 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.2%
15/286 • Number of events 15 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.9%
5/85 • Number of events 7 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.2%
1/80 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
7.5%
5/67 • Number of events 8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
2/47 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.5%
2/19 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.9%
5/85 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.0%
4/80 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.5%
1/67 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.5%
4/47 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
14.3%
7/49 • Number of events 10 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
15.8%
3/19 • Number of events 8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.7%
2/23 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
25.0%
2/8 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
25.0%
2/8 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
34/545 • Number of events 47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
7.2%
39/539 • Number of events 45 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.6%
19/286 • Number of events 24 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.4%
2/85 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
7.5%
6/80 • Number of events 6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
1.5%
1/67 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.2%
4/49 • Number of events 6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
1/23 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.5%
4/47 • Number of events 6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
1/23 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.6%
5/47 • Number of events 10 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Blood beta-D-glucan increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
2/47 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.1%
2/49 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.5%
2/19 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Blood glucose increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.4%
3/47 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.1%
2/49 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.4%
3/47 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Blood pressure increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Lipids abnormal
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Liver function test increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.5%
2/19 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.8%
6/47 • Number of events 13 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.2%
6/49 • Number of events 9 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.7%
2/23 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
37.5%
3/8 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.4%
3/47 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
Protein urine present
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
2/47 • Number of events 7 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Investigations
White blood cell count increased
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.1%
2/49 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
33.3%
2/6 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.2%
4/49 • Number of events 7 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
7.5%
41/545 • Number of events 51 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
7.4%
40/539 • Number of events 53 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
7.0%
20/286 • Number of events 23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
3.5%
3/85 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.2%
5/80 • Number of events 7 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
9.0%
6/67 • Number of events 7 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.4%
3/47 • Number of events 4 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
16.7%
1/6 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.2%
4/49 • Number of events 6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
1/23 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Headache
|
6.1%
33/545 • Number of events 36 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
3.5%
19/539 • Number of events 23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.5%
13/286 • Number of events 15 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.7%
4/85 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.2%
5/80 • Number of events 6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
7.5%
5/67 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.1%
1/47 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.1%
3/49 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
25.0%
2/8 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
4.3%
2/47 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.1%
3/49 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
2.0%
1/49 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.4%
3/47 • Number of events 3 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/19 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/545 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/539 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/286 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/49 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/23 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
|
Vascular disorders
Hypertension
|
5.5%
30/545 • Number of events 32 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.8%
31/539 • Number of events 32 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
6.6%
19/286 • Number of events 20 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/255 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/85 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/80 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/67 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/47 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
10.2%
5/49 • Number of events 5 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
5.3%
1/19 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
8.7%
2/23 • Number of events 2 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/6 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
0.00%
0/8 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
12.5%
1/8 • Number of events 1 • For both Global and Asian cohorts, AEs and SAEs were collected from the start of study intervention. For both cohorts, Pooled Placebo collected during the timeframe Week 0 to Week 12; Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Tofacitinib 5mg+csDMARD collected during the timeframe Week 12 to Week 59; and GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Tofacitinib 5mg+csDMARD collected during the timeframe Week 0 to Week 59.
The analysis was performed on the Safety Set for Pooled Placebo, GSK3196165 90 mg + MTX, GSK3196165 150 mg + MTX, Tofacitinib 5 mg + MTX. The analysis was performed on Safety Set-Period 2 for Placebo + MTX and GSK3196165 90 mg + MTX, Placebo + MTX and GSK3196165 150 mg + MTX, Placebo + MTX and Tofacitinib 5 mg + MTX.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER