Trial Outcomes & Findings for Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants (NCT NCT02065700)
NCT ID: NCT02065700
Last Updated: 2024-06-04
Results Overview
An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
739 participants
Primary outcome timeframe
From First dose to Week 437
Results posted on
2024-06-04
Participant Flow
Participants with moderately to severely active rheumatoid arthritis were enrolled in this study.
Participants from DARWIN1 or DARWIN2 were rolled over into this extension study. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
Participant milestones
| Measure |
Filgotinib Darwin 1
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
497
|
242
|
|
Overall Study
Male US Participants
|
7
|
0
|
|
Overall Study
COMPLETED
|
161
|
81
|
|
Overall Study
NOT COMPLETED
|
336
|
161
|
Reasons for withdrawal
| Measure |
Filgotinib Darwin 1
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Overall Study
Adverse Event
|
165
|
101
|
|
Overall Study
Withdrawal by Subject
|
90
|
29
|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Sponsor Request
|
38
|
15
|
|
Overall Study
Treatment Failure
|
3
|
2
|
|
Overall Study
Use of Non-permitted Concurrent Therapy
|
3
|
0
|
|
Overall Study
Adverse Event and Treatment Failure
|
0
|
2
|
|
Overall Study
Non-compliance with Study Procedures
|
2
|
0
|
|
Overall Study
Not Defined
|
21
|
3
|
Baseline Characteristics
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
Baseline characteristics by cohort
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
Total
n=739 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
52 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
53 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
405 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
603 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
208 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
289 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
446 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
374 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
555 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
119 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From First dose to Week 437Population: Safety Analysis Set. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events
|
453 participants
|
223 participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: The Full Analysis Set (FAS) included all participants who enrolled in the extension study and received at least one dose of study drug. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The American College of Rheumatology (ACR) response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in swollen joint count 66 (SJC66), and 2) ≥ 20% improvement from baseline in tender joint count 68 (TJC68), and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), 2.Subject's Global Assessment of Disease Activity (SGA) (VAS), 3. Physician's Global Assessment of Disease Activity (PGA) (VAS), 4. Total HAQ-DI score, and 5. High-Sensitivity C- Reactive Protein (hsCRP).
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 120
|
57.7 percentage of participants
|
59.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 156
|
50.7 percentage of participants
|
50.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 192
|
49.7 percentage of participants
|
48.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 288
|
36.6 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 408
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Extension Baseline
|
76.5 percentage of participants
|
77.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 12
|
83.9 percentage of participants
|
83.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 24
|
75.3 percentage of participants
|
77.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 36
|
75.1 percentage of participants
|
75.2 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 48
|
71.8 percentage of participants
|
71.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 60
|
67.8 percentage of participants
|
69.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 72
|
68.4 percentage of participants
|
62.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 84
|
65.8 percentage of participants
|
64.5 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 96
|
68.2 percentage of participants
|
61.6 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 108
|
61.6 percentage of participants
|
58.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 132
|
59.0 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 144
|
56.3 percentage of participants
|
57.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 168
|
52.3 percentage of participants
|
47.9 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 180
|
52.1 percentage of participants
|
51.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 204
|
48.9 percentage of participants
|
50.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 216
|
45.7 percentage of participants
|
50.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 228
|
47.9 percentage of participants
|
48.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 240
|
45.5 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 252
|
42.1 percentage of participants
|
42.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 264
|
39.4 percentage of participants
|
40.9 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 276
|
39.6 percentage of participants
|
44.2 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 300
|
35.6 percentage of participants
|
39.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 312
|
36.8 percentage of participants
|
36.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 324
|
36.6 percentage of participants
|
37.2 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 336
|
34.6 percentage of participants
|
35.5 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 348
|
33.2 percentage of participants
|
34.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 360
|
31.4 percentage of participants
|
31.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 372
|
30.0 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 384
|
28.0 percentage of participants
|
27.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Week 396
|
26.2 percentage of participants
|
28.5 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The ACR response was a measurement of improvement in multiple disease assessment criteria. The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 192
|
87.9 percentage of participants
|
88.7 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 180
|
89.0 percentage of participants
|
88.7 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Extension Baseline
|
77.4 percentage of participants
|
79.6 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 12
|
86.2 percentage of participants
|
87.4 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 24
|
84.8 percentage of participants
|
89.5 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 36
|
86.5 percentage of participants
|
89.2 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 48
|
84.6 percentage of participants
|
86.9 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 60
|
84.5 percentage of participants
|
90.8 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 72
|
87.9 percentage of participants
|
87.8 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 84
|
87.2 percentage of participants
|
91.8 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 96
|
89.9 percentage of participants
|
91.4 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 108
|
86.0 percentage of participants
|
89.2 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 120
|
85.9 percentage of participants
|
91.1 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 132
|
88.0 percentage of participants
|
92.1 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 144
|
86.7 percentage of participants
|
89.7 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 156
|
87.2 percentage of participants
|
89.7 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 168
|
87.2 percentage of participants
|
84.1 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 204
|
89.3 percentage of participants
|
91.8 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 216
|
86.6 percentage of participants
|
93.2 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 228
|
89.5 percentage of participants
|
92.9 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 240
|
88.3 percentage of participants
|
89.1 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 252
|
89.7 percentage of participants
|
91.9 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 264
|
86.3 percentage of participants
|
90.8 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 276
|
91.6 percentage of participants
|
93.9 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 288
|
87.9 percentage of participants
|
85.5 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 300
|
88.1 percentage of participants
|
91.4 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 312
|
88.8 percentage of participants
|
87.0 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 324
|
89.7 percentage of participants
|
86.5 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 336
|
88.7 percentage of participants
|
88.7 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 348
|
87.8 percentage of participants
|
91.3 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 360
|
86.7 percentage of participants
|
88.4 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 372
|
89.8 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 384
|
85.3 percentage of participants
|
84.8 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 396
|
85.0 percentage of participants
|
92.0 percentage of participants
|
|
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Week 408
|
66.7 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving ACR50 Response: NRI
Extension Baseline
|
48.5 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 12
|
60.8 percentage of participants
|
61.2 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 24
|
56.7 percentage of participants
|
60.3 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 36
|
58.1 percentage of participants
|
60.3 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 48
|
55.9 percentage of participants
|
53.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 60
|
53.9 percentage of participants
|
51.2 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 72
|
53.3 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 84
|
52.9 percentage of participants
|
51.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 96
|
55.5 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 108
|
49.1 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 120
|
48.7 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 132
|
47.5 percentage of participants
|
42.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 144
|
46.9 percentage of participants
|
43.0 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 156
|
42.3 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 168
|
43.9 percentage of participants
|
34.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 180
|
42.7 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 192
|
38.4 percentage of participants
|
37.6 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 204
|
37.8 percentage of participants
|
38.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 216
|
36.0 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 228
|
38.4 percentage of participants
|
34.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 240
|
34.2 percentage of participants
|
33.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 252
|
32.0 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 264
|
30.6 percentage of participants
|
33.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 276
|
29.6 percentage of participants
|
36.0 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 288
|
29.8 percentage of participants
|
33.5 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 300
|
29.2 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 312
|
29.0 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 324
|
30.0 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 336
|
27.4 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 348
|
27.2 percentage of participants
|
26.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 360
|
24.5 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 372
|
23.7 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 384
|
21.3 percentage of participants
|
21.5 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 396
|
19.9 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: NRI
Week 408
|
0.4 percentage of participants
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 192
|
67.5 percentage of participants
|
67.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 204
|
69.6 percentage of participants
|
69.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 228
|
72.1 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 240
|
66.9 percentage of participants
|
69.5 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 252
|
68.5 percentage of participants
|
71.2 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 264
|
66.7 percentage of participants
|
74.8 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 348
|
71.8 percentage of participants
|
69.6 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 324
|
72.7 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 336
|
70.1 percentage of participants
|
63.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Extension Baseline
|
49.4 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 12
|
62.4 percentage of participants
|
64.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 24
|
64.1 percentage of participants
|
69.2 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 36
|
67.2 percentage of participants
|
71.6 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 48
|
65.9 percentage of participants
|
65.3 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 60
|
67.3 percentage of participants
|
66.3 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 72
|
68.5 percentage of participants
|
65.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 84
|
69.9 percentage of participants
|
73.5 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 96
|
73.2 percentage of participants
|
69.5 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 108
|
68.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 120
|
72.9 percentage of participants
|
67.5 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 132
|
71.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 144
|
71.3 percentage of participants
|
67.5 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 156
|
72.4 percentage of participants
|
63.0 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 168
|
73.4 percentage of participants
|
60.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 180
|
72.6 percentage of participants
|
67.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 216
|
68.1 percentage of participants
|
64.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 276
|
68.1 percentage of participants
|
76.3 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 288
|
70.8 percentage of participants
|
73.6 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 300
|
72.5 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 312
|
69.6 percentage of participants
|
64.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 360
|
67.8 percentage of participants
|
67.4 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 372
|
70.7 percentage of participants
|
71.1 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 384
|
64.2 percentage of participants
|
65.0 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 396
|
65.6 percentage of participants
|
64.9 percentage of participants
|
|
Percentage of Participants Achieving ACR50 Response: OC
Week 408
|
66.7 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 396
|
14.9 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 408
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 120
|
36.0 percentage of participants
|
31.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 132
|
32.8 percentage of participants
|
29.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 144
|
31.6 percentage of participants
|
28.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 156
|
26.8 percentage of participants
|
22.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 168
|
30.8 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 180
|
30.8 percentage of participants
|
25.6 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 192
|
26.6 percentage of participants
|
25.2 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 204
|
26.6 percentage of participants
|
24.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 216
|
26.4 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 228
|
27.2 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 240
|
21.5 percentage of participants
|
21.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 252
|
21.7 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 264
|
23.1 percentage of participants
|
22.7 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 276
|
21.3 percentage of participants
|
24.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 288
|
22.1 percentage of participants
|
24.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 300
|
22.5 percentage of participants
|
19.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 312
|
23.1 percentage of participants
|
19.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 324
|
21.5 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 336
|
20.3 percentage of participants
|
17.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 348
|
19.7 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 360
|
17.7 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 372
|
16.7 percentage of participants
|
17.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 384
|
14.9 percentage of participants
|
14.9 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Extension Baseline
|
30.0 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 12
|
36.8 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 24
|
37.8 percentage of participants
|
39.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 36
|
40.6 percentage of participants
|
37.2 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 48
|
39.4 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 60
|
36.4 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 72
|
38.0 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 84
|
36.8 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 96
|
39.6 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: NRI
Week 108
|
35.4 percentage of participants
|
29.8 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The ACR response was a measurement of improvement in multiple disease assessment criteria. ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5.hsCRP.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 120
|
53.8 percentage of participants
|
47.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 300
|
55.4 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 312
|
55.3 percentage of participants
|
47.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Extension Baseline
|
30.3 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 12
|
37.7 percentage of participants
|
38.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 24
|
42.7 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 36
|
46.9 percentage of participants
|
44.6 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 48
|
46.6 percentage of participants
|
44.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 60
|
45.5 percentage of participants
|
44.6 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 72
|
48.7 percentage of participants
|
42.2 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 84
|
48.9 percentage of participants
|
48.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 96
|
52.5 percentage of participants
|
41.2 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 108
|
49.7 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 132
|
48.9 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 144
|
48.3 percentage of participants
|
44.2 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 156
|
45.5 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 168
|
51.5 percentage of participants
|
42.6 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 180
|
52.4 percentage of participants
|
44.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 192
|
46.6 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 204
|
49.1 percentage of participants
|
45.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 216
|
49.4 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 228
|
50.9 percentage of participants
|
46.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 240
|
42.1 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 252
|
46.4 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 264
|
50.7 percentage of participants
|
51.4 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 276
|
48.8 percentage of participants
|
53.1 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 288
|
52.4 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 324
|
52.2 percentage of participants
|
49.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 336
|
51.8 percentage of participants
|
44.3 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 348
|
51.6 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 360
|
49.2 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 372
|
49.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 384
|
45.4 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 396
|
49.0 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Achieving ACR70 Response: OC
Week 408
|
66.7 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
ACR-N was defined as the smallest percentage improvement from core baseline in SJC66, TJC68 and the median of the following 5 items (Pain VAS \[taken from the HAQ-DI\], 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP). It had a range between 0 and 100%.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
ACR N% Improvement (ACR-N) Response: OC
Week 396
|
61.5 percentage of improvement
Standard Deviation 31.34
|
64.7 percentage of improvement
Standard Deviation 28.98
|
|
ACR N% Improvement (ACR-N) Response: OC
Extension Baseline
|
48.1 percentage of improvement
Standard Deviation 30.29
|
46.3 percentage of improvement
Standard Deviation 27.77
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 12
|
56.3 percentage of improvement
Standard Deviation 28.43
|
56.3 percentage of improvement
Standard Deviation 27.13
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 24
|
57.9 percentage of improvement
Standard Deviation 29.64
|
60.8 percentage of improvement
Standard Deviation 27.76
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 36
|
59.8 percentage of improvement
Standard Deviation 29.70
|
60.7 percentage of improvement
Standard Deviation 27.95
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 48
|
59.6 percentage of improvement
Standard Deviation 30.69
|
58.9 percentage of improvement
Standard Deviation 28.65
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 60
|
59.9 percentage of improvement
Standard Deviation 29.97
|
60.1 percentage of improvement
Standard Deviation 28.43
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 72
|
61.4 percentage of improvement
Standard Deviation 28.92
|
59.0 percentage of improvement
Standard Deviation 28.47
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 84
|
61.6 percentage of improvement
Standard Deviation 29.07
|
63.6 percentage of improvement
Standard Deviation 26.74
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 96
|
64.8 percentage of improvement
Standard Deviation 28.61
|
61.2 percentage of improvement
Standard Deviation 26.87
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 108
|
61.2 percentage of improvement
Standard Deviation 30.22
|
60.9 percentage of improvement
Standard Deviation 28.69
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 120
|
63.4 percentage of improvement
Standard Deviation 29.25
|
61.1 percentage of improvement
Standard Deviation 28.72
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 132
|
62.3 percentage of improvement
Standard Deviation 29.15
|
61.3 percentage of improvement
Standard Deviation 28.52
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 144
|
61.7 percentage of improvement
Standard Deviation 28.99
|
60.8 percentage of improvement
Standard Deviation 29.12
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 156
|
61.5 percentage of improvement
Standard Deviation 28.05
|
58.0 percentage of improvement
Standard Deviation 27.70
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 168
|
62.8 percentage of improvement
Standard Deviation 29.75
|
56.9 percentage of improvement
Standard Deviation 30.25
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 180
|
63.2 percentage of improvement
Standard Deviation 28.29
|
59.9 percentage of improvement
Standard Deviation 29.79
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 192
|
60.4 percentage of improvement
Standard Deviation 29.15
|
61.5 percentage of improvement
Standard Deviation 27.30
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 204
|
62.3 percentage of improvement
Standard Deviation 28.64
|
61.9 percentage of improvement
Standard Deviation 26.79
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 216
|
61.6 percentage of improvement
Standard Deviation 29.87
|
61.4 percentage of improvement
Standard Deviation 26.86
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 228
|
64.2 percentage of improvement
Standard Deviation 27.83
|
63.0 percentage of improvement
Standard Deviation 26.45
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 240
|
59.8 percentage of improvement
Standard Deviation 28.22
|
60.6 percentage of improvement
Standard Deviation 28.48
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 252
|
62.4 percentage of improvement
Standard Deviation 28.71
|
62.5 percentage of improvement
Standard Deviation 26.24
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 264
|
63.4 percentage of improvement
Standard Deviation 29.81
|
64.4 percentage of improvement
Standard Deviation 27.05
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 276
|
63.3 percentage of improvement
Standard Deviation 28.27
|
65.9 percentage of improvement
Standard Deviation 25.42
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 288
|
65.1 percentage of improvement
Standard Deviation 29.68
|
63.0 percentage of improvement
Standard Deviation 29.82
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 300
|
64.9 percentage of improvement
Standard Deviation 30.16
|
61.9 percentage of improvement
Standard Deviation 27.14
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 312
|
64.8 percentage of improvement
Standard Deviation 29.89
|
59.9 percentage of improvement
Standard Deviation 30.37
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 324
|
65.9 percentage of improvement
Standard Deviation 27.39
|
61.2 percentage of improvement
Standard Deviation 30.98
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 336
|
62.7 percentage of improvement
Standard Deviation 29.35
|
59.8 percentage of improvement
Standard Deviation 28.90
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 348
|
64.8 percentage of improvement
Standard Deviation 29.26
|
62.8 percentage of improvement
Standard Deviation 28.29
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 360
|
62.7 percentage of improvement
Standard Deviation 29.81
|
61.2 percentage of improvement
Standard Deviation 28.32
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 372
|
64.2 percentage of improvement
Standard Deviation 28.58
|
64.6 percentage of improvement
Standard Deviation 29.43
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 384
|
60.0 percentage of improvement
Standard Deviation 30.27
|
62.9 percentage of improvement
Standard Deviation 30.43
|
|
ACR N% Improvement (ACR-N) Response: OC
Week 408
|
65.9 percentage of improvement
Standard Deviation 41.08
|
35.4 percentage of improvement
Standard Deviation 50.04
|
SECONDARY outcome
Timeframe: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The DAS28(CRP) was a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), SGA \[using a VAS on a scale of 0 (very well) to 100 (very poor)\] and hsCRP using the formula: DAS28(CRP) = 0.56 \* Square root \[SQRT\] (TJC28) + 0.28 \* SQRT(SJC28) + 0.36 \* Ln(CRP+1) + 0.014 \* SGA + 0.96 and the total possible score ranged from 1 to 9.4. Higher values indicated higher disease activity. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Extension Baseline
|
-2.7 score on a scale
Standard Deviation 1.40
|
-2.6 score on a scale
Standard Deviation 1.28
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 36
|
-3.3 score on a scale
Standard Deviation 1.28
|
-3.3 score on a scale
Standard Deviation 1.22
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 120
|
-3.4 score on a scale
Standard Deviation 1.20
|
-3.5 score on a scale
Standard Deviation 1.14
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 288
|
-3.5 score on a scale
Standard Deviation 1.22
|
-3.6 score on a scale
Standard Deviation 1.28
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 324
|
-3.6 score on a scale
Standard Deviation 1.14
|
-3.5 score on a scale
Standard Deviation 1.24
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 12
|
-3.1 score on a scale
Standard Deviation 1.28
|
-3.1 score on a scale
Standard Deviation 1.22
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 24
|
-3.2 score on a scale
Standard Deviation 1.29
|
-3.2 score on a scale
Standard Deviation 1.33
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 48
|
-3.3 score on a scale
Standard Deviation 1.32
|
-3.3 score on a scale
Standard Deviation 1.26
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 60
|
-3.3 score on a scale
Standard Deviation 1.22
|
-3.4 score on a scale
Standard Deviation 1.17
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 72
|
-3.3 score on a scale
Standard Deviation 1.23
|
-3.4 score on a scale
Standard Deviation 1.21
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 84
|
-3.4 score on a scale
Standard Deviation 1.21
|
-3.5 score on a scale
Standard Deviation 1.09
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 96
|
-3.4 score on a scale
Standard Deviation 1.22
|
-3.4 score on a scale
Standard Deviation 1.13
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 108
|
-3.4 score on a scale
Standard Deviation 1.22
|
-3.3 score on a scale
Standard Deviation 1.21
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 132
|
-3.3 score on a scale
Standard Deviation 1.21
|
-3.5 score on a scale
Standard Deviation 1.26
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 144
|
-3.4 score on a scale
Standard Deviation 1.19
|
-3.4 score on a scale
Standard Deviation 1.15
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 192
|
-3.3 score on a scale
Standard Deviation 1.16
|
-3.5 score on a scale
Standard Deviation 1.13
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 156
|
-3.4 score on a scale
Standard Deviation 1.22
|
-3.4 score on a scale
Standard Deviation 1.28
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 168
|
-3.4 score on a scale
Standard Deviation 1.27
|
-3.4 score on a scale
Standard Deviation 1.20
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 180
|
-3.4 score on a scale
Standard Deviation 1.12
|
-3.4 score on a scale
Standard Deviation 1.21
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 204
|
-3.4 score on a scale
Standard Deviation 1.16
|
-3.5 score on a scale
Standard Deviation 1.06
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 216
|
-3.4 score on a scale
Standard Deviation 1.16
|
-3.5 score on a scale
Standard Deviation 1.15
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 228
|
-3.5 score on a scale
Standard Deviation 1.12
|
-3.5 score on a scale
Standard Deviation 1.09
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 240
|
-3.4 score on a scale
Standard Deviation 1.13
|
-3.4 score on a scale
Standard Deviation 1.19
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 252
|
-3.5 score on a scale
Standard Deviation 1.11
|
-3.6 score on a scale
Standard Deviation 1.24
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 264
|
-3.5 score on a scale
Standard Deviation 1.19
|
-3.6 score on a scale
Standard Deviation 1.20
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 276
|
-3.5 score on a scale
Standard Deviation 1.10
|
-3.6 score on a scale
Standard Deviation 1.17
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 300
|
-3.6 score on a scale
Standard Deviation 1.19
|
-3.5 score on a scale
Standard Deviation 1.23
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 312
|
-3.5 score on a scale
Standard Deviation 1.27
|
-3.4 score on a scale
Standard Deviation 1.30
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 336
|
-3.5 score on a scale
Standard Deviation 1.17
|
-3.4 score on a scale
Standard Deviation 1.16
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 348
|
-3.5 score on a scale
Standard Deviation 1.20
|
-3.6 score on a scale
Standard Deviation 1.14
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 360
|
-3.6 score on a scale
Standard Deviation 1.21
|
-3.4 score on a scale
Standard Deviation 1.13
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 372
|
-3.6 score on a scale
Standard Deviation 1.18
|
-3.6 score on a scale
Standard Deviation 1.26
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 384
|
-3.4 score on a scale
Standard Deviation 1.24
|
-3.5 score on a scale
Standard Deviation 1.26
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 396
|
-3.5 score on a scale
Standard Deviation 1.38
|
-3.8 score on a scale
Standard Deviation 1.12
|
|
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Change from Core Baseline at Week 408
|
-3.8 score on a scale
Standard Deviation 0.97
|
-2.8 score on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm), CRP (mg/dL). SDAI = TJC + SJC + SGA + PGA+ CRP. The SDAI score ranged from 0 to approximately 86. Higher SDAI indicated greater disease activity. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Extension Baseline
|
-30.2 score on a scale
Standard Deviation 15.49
|
-29.8 score on a scale
Standard Deviation 14.27
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 12
|
-33.4 score on a scale
Standard Deviation 14.16
|
-34.1 score on a scale
Standard Deviation 13.79
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 24
|
-34.0 score on a scale
Standard Deviation 14.19
|
-35.0 score on a scale
Standard Deviation 14.65
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 36
|
-34.7 score on a scale
Standard Deviation 13.98
|
-35.9 score on a scale
Standard Deviation 13.42
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 48
|
-34.7 score on a scale
Standard Deviation 14.38
|
-36.2 score on a scale
Standard Deviation 14.08
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 60
|
-35.3 score on a scale
Standard Deviation 13.57
|
-36.3 score on a scale
Standard Deviation 12.85
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 72
|
-35.4 score on a scale
Standard Deviation 13.38
|
-36.7 score on a scale
Standard Deviation 13.41
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 84
|
-35.6 score on a scale
Standard Deviation 13.38
|
-37.3 score on a scale
Standard Deviation 13.12
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 96
|
-36.2 score on a scale
Standard Deviation 13.31
|
-36.8 score on a scale
Standard Deviation 13.47
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 108
|
-36.0 score on a scale
Standard Deviation 13.56
|
-36.6 score on a scale
Standard Deviation 13.65
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 120
|
-36.1 score on a scale
Standard Deviation 13.28
|
-37.4 score on a scale
Standard Deviation 12.90
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 132
|
-35.6 score on a scale
Standard Deviation 13.38
|
-36.9 score on a scale
Standard Deviation 14.25
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 144
|
-35.7 score on a scale
Standard Deviation 13.15
|
-36.9 score on a scale
Standard Deviation 13.12
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 156
|
-35.5 score on a scale
Standard Deviation 13.36
|
-36.9 score on a scale
Standard Deviation 14.46
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 168
|
-35.8 score on a scale
Standard Deviation 14.18
|
-36.9 score on a scale
Standard Deviation 13.84
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 180
|
-36.2 score on a scale
Standard Deviation 12.72
|
-36.9 score on a scale
Standard Deviation 13.33
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 192
|
-35.5 score on a scale
Standard Deviation 12.74
|
-38.2 score on a scale
Standard Deviation 13.66
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 204
|
-35.8 score on a scale
Standard Deviation 12.78
|
-38.5 score on a scale
Standard Deviation 13.72
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 216
|
-36.1 score on a scale
Standard Deviation 12.92
|
-38.0 score on a scale
Standard Deviation 13.85
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 228
|
-36.8 score on a scale
Standard Deviation 12.38
|
-37.9 score on a scale
Standard Deviation 12.87
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 240
|
-35.9 score on a scale
Standard Deviation 12.69
|
-37.1 score on a scale
Standard Deviation 14.38
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 252
|
-37.2 score on a scale
Standard Deviation 12.63
|
-38.6 score on a scale
Standard Deviation 14.85
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 264
|
-37.3 score on a scale
Standard Deviation 12.98
|
-39.2 score on a scale
Standard Deviation 14.59
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 276
|
-37.5 score on a scale
Standard Deviation 12.18
|
-38.6 score on a scale
Standard Deviation 13.98
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 288
|
-37.0 score on a scale
Standard Deviation 13.22
|
-38.6 score on a scale
Standard Deviation 15.09
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 300
|
-37.5 score on a scale
Standard Deviation 13.55
|
-38.0 score on a scale
Standard Deviation 15.38
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 312
|
-37.1 score on a scale
Standard Deviation 13.71
|
-37.7 score on a scale
Standard Deviation 15.54
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 324
|
-37.7 score on a scale
Standard Deviation 13.06
|
-38.1 score on a scale
Standard Deviation 15.56
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 336
|
-36.7 score on a scale
Standard Deviation 12.52
|
-36.6 score on a scale
Standard Deviation 14.36
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 348
|
-37.0 score on a scale
Standard Deviation 12.53
|
-37.2 score on a scale
Standard Deviation 13.02
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 360
|
-37.4 score on a scale
Standard Deviation 12.83
|
-36.3 score on a scale
Standard Deviation 13.05
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 372
|
-37.3 score on a scale
Standard Deviation 12.68
|
-37.8 score on a scale
Standard Deviation 13.64
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 384
|
-36.5 score on a scale
Standard Deviation 12.64
|
-36.5 score on a scale
Standard Deviation 14.58
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 396
|
-36.3 score on a scale
Standard Deviation 14.32
|
-39.5 score on a scale
Standard Deviation 13.50
|
|
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Change from Core Baseline at Week 408
|
-40.4 score on a scale
Standard Deviation 12.91
|
-35.6 score on a scale
Standard Deviation 5.98
|
SECONDARY outcome
Timeframe: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The CDAI was the SDAI modified that excluded CRP and consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm). SDAI = TJC + SJC + SGA+ PGA. The CDAI score ranged from 0 to approximately 76. Higher CDAI indicated greater disease activity. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 228
|
-35.2 score on a scale
Standard Deviation 11.69
|
-35.8 score on a scale
Standard Deviation 11.98
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 12
|
-31.8 score on a scale
Standard Deviation 13.45
|
-32.4 score on a scale
Standard Deviation 12.76
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 24
|
-32.4 score on a scale
Standard Deviation 13.63
|
-32.9 score on a scale
Standard Deviation 13.79
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 312
|
-35.5 score on a scale
Standard Deviation 13.10
|
-35.5 score on a scale
Standard Deviation 14.40
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 324
|
-35.8 score on a scale
Standard Deviation 12.30
|
-36.0 score on a scale
Standard Deviation 14.37
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 396
|
-34.7 score on a scale
Standard Deviation 13.28
|
-34.2 score on a scale
Standard Deviation 12.55
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Extension Baseline
|
-28.8 score on a scale
Standard Deviation 14.58
|
-28.0 score on a scale
Standard Deviation 13.68
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 36
|
-33.0 score on a scale
Standard Deviation 13.44
|
-33.8 score on a scale
Standard Deviation 12.51
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 48
|
-33.1 score on a scale
Standard Deviation 13.79
|
-34.1 score on a scale
Standard Deviation 13.18
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 60
|
-33.7 score on a scale
Standard Deviation 12.97
|
-34.2 score on a scale
Standard Deviation 12.22
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 72
|
-33.8 score on a scale
Standard Deviation 12.73
|
-34.4 score on a scale
Standard Deviation 12.57
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 84
|
-33.9 score on a scale
Standard Deviation 12.82
|
-35.2 score on a scale
Standard Deviation 12.31
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 96
|
-34.6 score on a scale
Standard Deviation 12.76
|
-34.7 score on a scale
Standard Deviation 12.56
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 108
|
-34.3 score on a scale
Standard Deviation 12.96
|
-34.5 score on a scale
Standard Deviation 12.92
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 120
|
-34.5 score on a scale
Standard Deviation 12.70
|
-35.2 score on a scale
Standard Deviation 11.87
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 132
|
-34.1 score on a scale
Standard Deviation 12.82
|
-34.7 score on a scale
Standard Deviation 13.07
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 144
|
-34.1 score on a scale
Standard Deviation 12.63
|
-34.9 score on a scale
Standard Deviation 12.12
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 156
|
-34.0 score on a scale
Standard Deviation 12.74
|
-34.8 score on a scale
Standard Deviation 13.29
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 168
|
-34.1 score on a scale
Standard Deviation 13.64
|
-34.8 score on a scale
Standard Deviation 12.55
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 180
|
-34.5 score on a scale
Standard Deviation 12.10
|
-34.8 score on a scale
Standard Deviation 12.39
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 192
|
-33.9 score on a scale
Standard Deviation 12.10
|
-35.9 score on a scale
Standard Deviation 12.65
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 204
|
-34.2 score on a scale
Standard Deviation 12.26
|
-36.3 score on a scale
Standard Deviation 12.79
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 216
|
-34.5 score on a scale
Standard Deviation 12.18
|
-36.0 score on a scale
Standard Deviation 13.00
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 240
|
-34.3 score on a scale
Standard Deviation 11.99
|
-35.2 score on a scale
Standard Deviation 13.27
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 252
|
-35.3 score on a scale
Standard Deviation 11.94
|
-36.4 score on a scale
Standard Deviation 13.55
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 264
|
-35.6 score on a scale
Standard Deviation 12.15
|
-36.9 score on a scale
Standard Deviation 13.53
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 276
|
-35.9 score on a scale
Standard Deviation 11.38
|
-36.4 score on a scale
Standard Deviation 12.84
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 288
|
-35.4 score on a scale
Standard Deviation 12.28
|
-36.5 score on a scale
Standard Deviation 13.47
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 300
|
-35.8 score on a scale
Standard Deviation 12.84
|
-35.7 score on a scale
Standard Deviation 14.29
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 336
|
-35.0 score on a scale
Standard Deviation 11.76
|
-34.2 score on a scale
Standard Deviation 13.32
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 348
|
-35.3 score on a scale
Standard Deviation 11.70
|
-34.8 score on a scale
Standard Deviation 11.73
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 360
|
-35.5 score on a scale
Standard Deviation 12.00
|
-34.0 score on a scale
Standard Deviation 11.54
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 372
|
-35.4 score on a scale
Standard Deviation 12.46
|
-33.9 score on a scale
Standard Deviation 12.73
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 384
|
-34.8 score on a scale
Standard Deviation 11.82
|
-32.6 score on a scale
Standard Deviation 13.11
|
|
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Change from Core Baseline at Week 408
|
-39.2 score on a scale
Standard Deviation 12.87
|
-34.9 score on a scale
Standard Deviation 6.36
|
SECONDARY outcome
Timeframe: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
DAS28(CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None= Actual DAS28(CRP) ≤ 3.2, \> 3.2 to ≤ 5.1, or \> 5.1 AND Improvement in DAS28(CRP) from baseline ≤ 6.0 or \> 0.6 to ≤ 1.2; Moderate= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline \> 0.6 to ≤ 1.2, Actual DAS28(CRP) \> 3.2 to ≤ 5.1 or \> 5.1 AND Improvement in DAS28(CRP) from baseline \> 1.2, or Actual DAS28(CRP) \> 3.2 to ≤ 5.1 AND Improvement in DAS28(CRP) from baseline \> 0.6 to ≤ 1.2; Good= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline \> 1.2.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Extension Baseline: Moderate
|
43.6 percentage of participants
|
48.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 12: Good
|
59.1 percentage of participants
|
60.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 60: Moderate
|
29.9 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 60: None
|
2.3 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 72: Good
|
70.5 percentage of participants
|
65.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 72: Moderate
|
26.7 percentage of participants
|
32.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 72: None
|
2.8 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 84: Good
|
70.3 percentage of participants
|
69.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 84: Moderate
|
27.6 percentage of participants
|
29.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 84: None
|
2.1 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 96: Good
|
72.9 percentage of participants
|
69.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 96: Moderate
|
25.2 percentage of participants
|
27.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 96: None
|
1.9 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 108: Good
|
74.2 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 108: Moderate
|
23.6 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 108: None
|
2.2 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 120: Good
|
74.6 percentage of participants
|
67.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 204: None
|
2.9 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 264: Moderate
|
24.2 percentage of participants
|
22.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 408: Good
|
100.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 36: Moderate
|
29.7 percentage of participants
|
30.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 288: Moderate
|
24.5 percentage of participants
|
24.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 288: None
|
1.9 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 300: Good
|
74.8 percentage of participants
|
74.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 300: Moderate
|
23.8 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Extension Baseline: Good
|
46.2 percentage of participants
|
41.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Extension Baseline: None
|
10.2 percentage of participants
|
9.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 12: Moderate
|
35.5 percentage of participants
|
34.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 12: None
|
5.3 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 24: Good
|
65.2 percentage of participants
|
65.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 24: Moderate
|
29.3 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 24: None
|
5.4 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 36: Good
|
66.4 percentage of participants
|
66.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 36: None
|
3.9 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 48: Good
|
67.7 percentage of participants
|
68.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 48: Moderate
|
27.8 percentage of participants
|
27.4 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 48: None
|
4.5 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 60: Good
|
67.8 percentage of participants
|
64.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 300: None
|
1.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 120: Moderate
|
23.7 percentage of participants
|
29.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 120: None
|
1.8 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 132: Good
|
69.1 percentage of participants
|
69.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 132: Moderate
|
28.8 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 132: None
|
2.1 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 144: Good
|
72.3 percentage of participants
|
65.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 144: Moderate
|
25.8 percentage of participants
|
33.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 144: None
|
1.8 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 156: Good
|
69.0 percentage of participants
|
64.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 156: Moderate
|
28.3 percentage of participants
|
30.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 156: None
|
2.8 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 168: Good
|
73.4 percentage of participants
|
68.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 168: Moderate
|
23.6 percentage of participants
|
29.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 168: None
|
3.0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 180: Good
|
74.0 percentage of participants
|
68.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 180: Moderate
|
25.3 percentage of participants
|
28.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 180: None
|
0.7 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 192: Good
|
71.2 percentage of participants
|
71.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 192: Moderate
|
26.3 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 192: None
|
2.5 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 204: Good
|
73.3 percentage of participants
|
76.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 204: Moderate
|
23.8 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 216: Good
|
72.7 percentage of participants
|
69.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 216: Moderate
|
26.1 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 216: None
|
1.1 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 228: Good
|
76.4 percentage of participants
|
70.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 228: Moderate
|
23.6 percentage of participants
|
29.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 228: None
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 240: Good
|
73.2 percentage of participants
|
63.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 240: Moderate
|
26.1 percentage of participants
|
36.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 240: None
|
0.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 252: Good
|
74.2 percentage of participants
|
73.4 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 252: Moderate
|
24.5 percentage of participants
|
25.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 252: None
|
1.3 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 264: Good
|
74.4 percentage of participants
|
75.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 264: None
|
1.3 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 276: Good
|
74.4 percentage of participants
|
70.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 276: Moderate
|
25.1 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 276: None
|
0.5 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 288: Good
|
73.6 percentage of participants
|
73.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 312: Good
|
75.8 percentage of participants
|
66.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 312: Moderate
|
22.2 percentage of participants
|
32.7 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 312: None
|
1.9 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 324: Good
|
75.7 percentage of participants
|
71.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 324: Moderate
|
21.8 percentage of participants
|
26.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 324: None
|
2.5 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 336: Good
|
74.2 percentage of participants
|
71.9 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 336: Moderate
|
24.7 percentage of participants
|
26.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 336: None
|
1.0 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 348: Good
|
76.9 percentage of participants
|
78.5 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 348: Moderate
|
21.5 percentage of participants
|
20.4 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 348: None
|
1.6 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 360: Good
|
73.3 percentage of participants
|
73.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 360: Moderate
|
23.9 percentage of participants
|
24.4 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 360: None
|
2.8 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 372: Good
|
76.8 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 372: Moderate
|
21.3 percentage of participants
|
18.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 372: None
|
1.9 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 384: Good
|
70.3 percentage of participants
|
78.1 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 384: Moderate
|
28.4 percentage of participants
|
20.3 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 384: None
|
1.3 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 396: Good
|
73.2 percentage of participants
|
81.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 396: Moderate
|
21.7 percentage of participants
|
19.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 396: None
|
5.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 408: Moderate
|
0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Week 408: None
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS. NRI: Participants with missing outcomes were set as nonresponders for binary response measurements. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Extension Baseline
|
10.1 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 12
|
13.1 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 24
|
14.9 percentage of participants
|
15.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 36
|
15.3 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 48
|
17.7 percentage of participants
|
14.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 60
|
15.5 percentage of participants
|
12.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 72
|
15.5 percentage of participants
|
12.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 84
|
15.1 percentage of participants
|
12.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 96
|
18.3 percentage of participants
|
11.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 108
|
14.9 percentage of participants
|
10.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 120
|
12.3 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 132
|
12.1 percentage of participants
|
12.8 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 144
|
10.5 percentage of participants
|
9.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 156
|
10.9 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 168
|
13.9 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 180
|
10.3 percentage of participants
|
11.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 192
|
10.1 percentage of participants
|
10.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 204
|
11.1 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 216
|
11.5 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 228
|
11.9 percentage of participants
|
9.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 240
|
8.9 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 252
|
7.8 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 264
|
11.3 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 276
|
8.9 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 288
|
10.1 percentage of participants
|
9.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 300
|
10.9 percentage of participants
|
8.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 312
|
10.5 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 324
|
9.5 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 336
|
8.5 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 348
|
9.1 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 360
|
9.3 percentage of participants
|
6.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 372
|
8.2 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 384
|
6.6 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 396
|
7.8 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Week 408
|
0.4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 276
|
20.2 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 288
|
23.3 percentage of participants
|
21.6 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 384
|
20.0 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 396
|
25.2 percentage of participants
|
16.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 408
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Extension Baseline
|
10.1 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 12
|
13.3 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 24
|
16.6 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 36
|
17.5 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 48
|
20.7 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 60
|
19.2 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 72
|
19.7 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 84
|
19.7 percentage of participants
|
17.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 96
|
24.0 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 108
|
20.6 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 120
|
17.9 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 132
|
17.9 percentage of participants
|
19.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 144
|
15.8 percentage of participants
|
15.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 156
|
18.2 percentage of participants
|
14.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 168
|
23.1 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 180
|
17.4 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 192
|
17.4 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 204
|
19.9 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 216
|
21.2 percentage of participants
|
14.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 228
|
22.0 percentage of participants
|
18.6 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 240
|
16.8 percentage of participants
|
14.6 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 252
|
16.3 percentage of participants
|
16.8 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 264
|
24.2 percentage of participants
|
16.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 300
|
26.3 percentage of participants
|
19.6 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 312
|
24.8 percentage of participants
|
18.1 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 324
|
22.7 percentage of participants
|
23.8 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 336
|
21.3 percentage of participants
|
18.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 348
|
23.7 percentage of participants
|
23.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 360
|
24.9 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/EULAR Remission: OC
Week 372
|
24.6 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components: * Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items). * Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items). These scales were from 0 to 100 with higher scores indicating a better quality of life.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 96
|
12.2 score on a scale
Standard Deviation 9.70
|
11.8 score on a scale
Standard Deviation 8.87
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 144
|
11.8 score on a scale
Standard Deviation 9.86
|
12.2 score on a scale
Standard Deviation 9.21
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Extension Baseline
|
9.2 score on a scale
Standard Deviation 9.11
|
9.5 score on a scale
Standard Deviation 8.85
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 48
|
11.3 score on a scale
Standard Deviation 9.45
|
11.5 score on a scale
Standard Deviation 8.74
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 192
|
11.2 score on a scale
Standard Deviation 9.21
|
11.0 score on a scale
Standard Deviation 9.40
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 240
|
10.9 score on a scale
Standard Deviation 9.58
|
11.4 score on a scale
Standard Deviation 9.29
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 288
|
13.0 score on a scale
Standard Deviation 10.71
|
13.1 score on a scale
Standard Deviation 9.50
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 336
|
12.8 score on a scale
Standard Deviation 10.12
|
12.0 score on a scale
Standard Deviation 8.79
|
|
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Change from Core Baseline at Week 384
|
11.5 score on a scale
Standard Deviation 9.97
|
11.7 score on a scale
Standard Deviation 8.00
|
SECONDARY outcome
Timeframe: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components: * Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items). * Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items). These scales were from 0 to 100 with higher scores indicating a better quality of life.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 48
|
6.2 score on a scale
Standard Deviation 10.52
|
6.8 score on a scale
Standard Deviation 10.84
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 96
|
6.5 score on a scale
Standard Deviation 10.54
|
6.7 score on a scale
Standard Deviation 10.33
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 192
|
6.1 score on a scale
Standard Deviation 11.47
|
7.5 score on a scale
Standard Deviation 11.60
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Extension Baseline
|
6.1 score on a scale
Standard Deviation 9.67
|
7.1 score on a scale
Standard Deviation 10.01
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 144
|
6.2 score on a scale
Standard Deviation 10.72
|
6.6 score on a scale
Standard Deviation 10.86
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 240
|
6.5 score on a scale
Standard Deviation 11.11
|
7.7 score on a scale
Standard Deviation 11.66
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 288
|
7.3 score on a scale
Standard Deviation 11.49
|
8.2 score on a scale
Standard Deviation 11.20
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 336
|
6.7 score on a scale
Standard Deviation 10.49
|
6.6 score on a scale
Standard Deviation 13.65
|
|
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Change from Core Baseline at Week 384
|
6.3 score on a scale
Standard Deviation 11.23
|
8.0 score on a scale
Standard Deviation 10.98
|
SECONDARY outcome
Timeframe: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384Population: FAS with available data was analyzed. OC: only observed values were used for analysis. No missing data imputation was performed. Different participants could be analyzed at different timepoints, resulting in overall FAS participants being analyzed. As prespecified in the protocol, data was collected and analyzed based on their originating parent study i.e. DARWIN 1 and DARWIN 2.
FACIT-Fatigue scale was a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). Negatively stated items were reversed by subtracting the response from "4" before being added to obtain a total score. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating less fatigue. A positive change from baseline indicated better quality of life.
Outcome measures
| Measure |
Filgotinib Darwin 1
n=497 Participants
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 Participants
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 48
|
11.6 score on a scale
Standard Deviation 11.16
|
12.7 score on a scale
Standard Deviation 11.62
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 96
|
12.0 score on a scale
Standard Deviation 11.59
|
12.9 score on a scale
Standard Deviation 10.97
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 144
|
12.3 score on a scale
Standard Deviation 11.31
|
13.2 score on a scale
Standard Deviation 11.92
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Extension Baseline
|
10.7 score on a scale
Standard Deviation 11.06
|
12.1 score on a scale
Standard Deviation 10.71
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 192
|
11.7 score on a scale
Standard Deviation 11.63
|
12.8 score on a scale
Standard Deviation 11.96
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 240
|
11.5 score on a scale
Standard Deviation 11.52
|
12.5 score on a scale
Standard Deviation 11.74
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 288
|
13.4 score on a scale
Standard Deviation 13.21
|
15.0 score on a scale
Standard Deviation 12.03
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 336
|
13.2 score on a scale
Standard Deviation 12.18
|
13.8 score on a scale
Standard Deviation 12.29
|
|
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Change from Core Baseline at Week 384
|
12.6 score on a scale
Standard Deviation 13.35
|
13.9 score on a scale
Standard Deviation 10.76
|
Adverse Events
Filgotinib Darwin 1
Serious events: 84 serious events
Other events: 386 other events
Deaths: 8 deaths
Filgotinib Darwin 2
Serious events: 48 serious events
Other events: 189 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Filgotinib Darwin 1
n=497 participants at risk
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 participants at risk
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
1.2%
3/242 • Number of events 3 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue neoplasm
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.83%
2/242 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.60%
3/497 • Number of events 3 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Vascular disorders
Dry gangrene
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Vascular disorders
Hypertension
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
General disorders
Asthenia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
General disorders
Pyrexia
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Immune system disorders
Anaphylactic reaction
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Reproductive system and breast disorders
Colpocele
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.20%
1/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Respiratory, thoracic and mediastinal disorders
Caplan's syndrome
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Investigations
Electrocardiogram Q wave abnormal
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.60%
3/497 • Number of events 3 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.83%
2/242 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.83%
2/242 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Angina unstable
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
3/497 • Number of events 3 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Seizure
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
1/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Eye disorders
Amaurosis fugax
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Eye disorders
Cataract
|
0.20%
1/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Eye disorders
Glaucoma
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Eye disorders
Lens dislocation
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
5/497 • Number of events 5 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.20%
1/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.83%
2/242 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Renal and urinary disorders
Renal colic
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.20%
1/497 • Number of events 3 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
7/497 • Number of events 9 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
1.2%
3/242 • Number of events 4 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Wrist deformity
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Abdominal wall infection
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Atypical pneumonia
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
COVID-19
|
0.60%
3/497 • Number of events 3 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.2%
6/497 • Number of events 6 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.83%
2/242 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Diverticulitis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Herpes zoster
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Influenza
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Meningitis meningococcal
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Pneumonia
|
1.4%
7/497 • Number of events 7 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
1.2%
3/242 • Number of events 3 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Pneumonia influenzal
|
0.40%
2/497 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Respiratory tract infection
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Tracheobronchitis
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.83%
2/242 • Number of events 2 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/497 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.41%
1/242 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Wound infection
|
0.20%
1/497 • Number of events 1 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
0.00%
0/242 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
Other adverse events
| Measure |
Filgotinib Darwin 1
n=497 participants at risk
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 mg in this extension study, with the exception of male participants in the US who were limited to a daily dose of 100 mg due to an FDA requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
|
Filgotinib Darwin 2
n=242 participants at risk
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg q.d in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
|
|---|---|---|
|
Investigations
Blood cholesterol increased
|
2.6%
13/497 • Number of events 18 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
9.5%
23/242 • Number of events 42 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Investigations
Mycobacterium tuberculosis complex test positive
|
11.7%
58/497 • Number of events 59 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
16.5%
40/242 • Number of events 40 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Investigations
Lymphocyte count decreased
|
4.0%
20/497 • Number of events 31 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
7.4%
18/242 • Number of events 38 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Investigations
Blood creatinine increased
|
2.6%
13/497 • Number of events 14 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
8.3%
20/242 • Number of events 25 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Vascular disorders
Hypertension
|
15.1%
75/497 • Number of events 83 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
11.2%
27/242 • Number of events 37 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Nervous system disorders
Headache
|
6.8%
34/497 • Number of events 45 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
10.7%
26/242 • Number of events 41 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
45/497 • Number of events 65 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
9.5%
23/242 • Number of events 33 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
33/497 • Number of events 40 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
5.0%
12/242 • Number of events 13 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
37/497 • Number of events 41 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
4.1%
10/242 • Number of events 15 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
8.2%
41/497 • Number of events 78 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
6.2%
15/242 • Number of events 23 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Bronchitis
|
11.9%
59/497 • Number of events 86 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
7.9%
19/242 • Number of events 22 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
COVID-19
|
6.8%
34/497 • Number of events 37 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
4.1%
10/242 • Number of events 10 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Herpes zoster
|
5.8%
29/497 • Number of events 32 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
5.8%
14/242 • Number of events 14 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Gastroenteritis
|
5.8%
29/497 • Number of events 32 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
3.3%
8/242 • Number of events 10 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Influenza
|
6.0%
30/497 • Number of events 39 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
5.0%
12/242 • Number of events 16 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Nasopharyngitis
|
14.1%
70/497 • Number of events 112 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
9.9%
24/242 • Number of events 37 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
57/497 • Number of events 82 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
15.3%
37/242 • Number of events 50 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Pharyngitis
|
6.2%
31/497 • Number of events 41 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
4.5%
11/242 • Number of events 13 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Infections and infestations
Urinary tract infection
|
14.5%
72/497 • Number of events 128 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
12.4%
30/242 • Number of events 58 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.8%
39/497 • Number of events 54 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
12.4%
30/242 • Number of events 54 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
7.8%
39/497 • Number of events 53 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
7.0%
17/242 • Number of events 22 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.6%
18/497 • Number of events 28 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
5.4%
13/242 • Number of events 44 • From First dose to Week 437
Safety Analysis Set. As per planned analysis, data was collected and analyzed based on the parent study i.e. DARWIN 1 and DARWIN 2. No comparison/collection/analysis was planned based on extension study dose as it was not considered meaningful.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER